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dero
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PostSubject: My story...   Sun Dec 09, 2007 6:19 pm

A long read but there are no other ways to do it, you can not condense this.
The begining, why me???

To start off, some may know me as dero or Denis, I'm a 47 year old male, in pretty good physical shape and yes, this past july (2007) for no apparent reasons I have develloped a blood clot in my right leg. Two weeks prior to this, I suffered a gastrocnemius strain (diagnosed at a sport clinic) due to a hyperextension of my right calf and other muscles( my Dr. at the TAT unit ASSURED me that it was not the reason why I have DVT). Two weeks after my gastrocnemius strain, on the monday, I was scheduled to start physio therapy, but the night before, my thigh doubled in size (swelled up) and it was hurting in such a way I had never felt before (not a muscle pain, I have had my share of muscle pains during my life). Ignorant to what DVT was, like most of you were before you were diagnosed with DVT (Yet, most Americans (74 percent) have little or no awareness of DVT, according to a national survey sponsored by the American Public Health Association).
I went to see my GP the following morning( that monday) and as soon as he saw my leg, he knew what was happening, he arranged for me to have an appointement at the ER of the nearest hospital for an ultrasound test (AKA doppler test). That is when I was diagnosed for a blood clot in my right leg and it was large in size(my leg was clogged from my calf to my pelvis) affraid I was then (well, six hrs later,actually) injected with heparin and was sent home and was told that the following morning I would be contacted by somebody from the" TAT dept" at another hospital. (WHAT IS THE TAT dept.??? scratch "Thrombosis Assessment and Treatment dept"). That night, I did numerous google search on DVT to educate myself about this unknown (to me) disease. That is when I realised that DVT was no "take two aspirin and call me in the morning" sort of thing. I did get the phone call from the TAT unit at the Civic Hospital in Ottawa and was scheduled for my first appointement, that same day. There, I learned to self inject myself because I needed a daily injection of fragmin,dalterin sodium 18,000 IU (bloodthinners) every 24 hrs, for a week.
That is also when I started to take warfarin ( 2.5MG pills) more blood thinners Suspect
I originally started by taking a daily 10 mg dose of warfarin, once I stopped injecting myself, my warfarin intake was boosted to 15 mg./day. Over the following two weeks, my warfarin intake fluctuated, as my Dr. was trying to regulate my warfarin levels appropriate for me. ( I went as high as taking 15 mg of warfarin/day to as low as 5mg) I was having an INR done every second day for the first week, then every three day and then four... At one point the technician at the TAT unit told me that she thought she had FINALLY found my warfarin dosage. I just had to be consistent with my diet and my vitamine K intake (*READ AND UNDERSTAND VITAMIN K*).


The next phase.

Once I started the treatment (pills and injections and very little physical activities ), the two first weeks were the hardest for me, due to the fact that with the ammount of blood thinners in my system, I COULD NOT cut myself because I could bleed to death if the bleeding was not controled . At this point you want to stay in a SAFE ENVIRONEMENT, you become very paranoid of your every steps, you give yourself a "safe zone" where no scratch or cut can happen to you, now how stressfull is that, Shocked on top of this disease? This is also where I had to start watching my vitamin K intake, I had to be consistent with my daily intake. It does NOT mean that you shy away from vitamin K, you need those vegetables, it means that if you eat lots of vegetables you don't change a thing, you keep eating the same amount EVERY DAY same as if youre daily vegetable is minimal, you keep it the same every day, BE CONSISTENT. You have to understand that vitamin K is an coagulant found mainly in the dark green leafy vegetables like spinach, broccoli, I also needed numerous blood test called INR to be sure that my blood coagulation was (on a latter of 1 to 10) between 2.0 and 3.0, the more stable your INRs are, the less you need these blood tests.(presently,in December I have a INR every four weeks).

Ah, the compression sock . When I started the threatment (pills and injections) I was also enrolled in this study, to determine if the compression sock was affective for DVT outpatients or not, I was asked a bunch of questions about my lifestyle, health habits, work habits, social habits, in other word, it touched every thing that was ME.
Then, I was told that I had to wear this sock almost 24/7, for the next two years, well except for when I was sleeping. The part of the study which was unnerving (more stress...) was that nobody knew (not even my Dr.) if I was wearing a real compression sock or a placebo sock (am I wearing something that is doing nothing to help me, am I missing out???). Two weeks after I started wearing the sock, I developped an allergic reaction to it, so I was taken off the study and I don't wear the sock anymore, maybe this will be something that I will pay for later... (to be determine at a later date.)
End of november, my leg swells up an hour, hour and half after I get up, the pain and cramps are still there, but NOT as bad as in the begining, nothing like that . I had another ultrasound test done, to see how the clot was doing, it has diminished in size. A misconception that many people have, is that warfarin is responsible for this, it is'nt, it prevents your blood from coagulating, therefor, prevents anymore clotting, a natural function of the body takes care of diminishing the size of the clot. Then talking with my Dr., I asked her if the swelling and the pain at this time was normal and yes was the answer, it varies from person to person but usually after 6 months to a year the swelling and the pain should go away.
I'm not there yet.
So far, I have not mentioned that I was an AVID mountain bike rider, I have been for at least 10 years, when I say avid, I mean this is a lifestyle not just a hobby that I do occasionly, to the extent that I'm the president of an organisation that manages and maintane a mountain bike trail network, I'm also the rep for an international organisation IMBA Canada and also a provincial organisation ADSVMQ in my area. Needless to say that this summer, I have not been able to enjoy this sport, being an extreme sport, the dangers of crashing and cutting myself are ever so present. At my last appt. with my Dr., she told me that after concluding a recent study, it was proven that males that have had a DVT experience have a 19% chance of having a reccuring clot if taken off of warfarin, so she suggested that I become a "long term" warfarin user and that meant that I MAY have to stop something that may have prevented me from having a pulmonary embolism affraid (she knows to what extent I enjoy mountain biking)
but this decission does not have to be taken right now... My next ultrasound is in May 2008.


The emotional rollercoaster

Like I mentioned previously, this disease is not only taxing physically, it takes hold of your emotions and twists them in and out of shape, at first, the unknown, followed by all the discoveries of how dangerous DVT really is if it takes a wrong turn, that the drugs you are taking may be harmfull to you, then it changes your whole lifestyle entierlly!!!
What I have just described, is only one version of how DVT can affect you, many people have died from it, which is at the opposite end of this spectrum. DVT blood clots affect up to 2 million Americans each year, and complications kill up to 200,000 people inthe U.S. annually -- more than breast cancer and AIDS combined.
Now you may understand the "for some of us" part on the main loggo, and you may understand what it does to my mind and the minds of people who are affected by DVT.

I'm not asking for pity or anything like that, nor do I want to scare people, I'm simply telling it as it is, so that people who do read this will become aware of the severity of DVT.
Before I contracted DVT...I had no idea.
I know for a fact that many other people are affected differently then I am by DVT and I hope that they will tell their stories so that more people can benifit from it and become aware of the dangers of DVT.

I hope that this forum will help people that are discovering that they have DVT, I know they will have many questions.
I know I did...
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PostSubject: Re: My story...   Thu Jan 03, 2008 4:42 pm

Like previously stated, warfarin and extrem sports do not go hand and hand, to many chances of cutting yourself on a crash during a mountain bike ride, rocks and short stubby branches are all over the place, the worst are the blackberry plants this was taken after a ride during the begining of the blackberry season, you can just imagine my arms during the peaktime of blackberry season...
Yes, I have come to the conclussion and the realisation that I will not go in the bushes on my bike as long as I am still taking warfarin.
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Sharon

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Age : 59
Location : Friendswood, Texas--USA

PostSubject: Re: My story...   Fri Jan 04, 2008 3:23 am

I'm really glad you decided this way Dero. I know it is a sacrifice for you to give it up for awhile, but it is worth it to keep yourself safe. We need you on this forum! I'm really impressed too that you have turned all that energy into something as constructive as setting this up for all of us. I really appreciate it, and as more and more people find it, I know they will too!
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PostSubject: Re: My story...   Thu Jan 17, 2008 11:31 pm

YAY!!! cheers INR 2.6,
next INR Feb 07/08.

This morning I received a phone call from the "Research Co-ordinator of the Thrombosis Program" for the Thrombosis Assesment and Threatment(TAT) Unit at the hospital here in Ottawa (major research centre for thrombosis), she phoned me to set a follow-up (6 months post diagnose)appt. Originally ,I was part of this study case to determine if the compression sock was in fact helping or not DVT out patients, I stopped wearing the sock 2 weeks into the study, because I developped an allergic reaction to it. I thought that since I was not wearing the sock it meant that I was off the study, but she told me that I was still part of the study, as a patient that can not wear the sock...
I have an appt next monday, jan 21 (measure my leg, answer questions...)but she also wants to talk about another study that I could get on. This would be to start on this drug that is in it's 3rd phase ( if it pass phase 3 and is approved by the FDA, it would be on the market in 2010 , the earliest...)
It is an anticoagulant that is call dabigatran etexilate(150 mg bid) that may eventually replace the warfarin (INR 2.0-3.0) for the secondary prevention of venous thrombolism. I have to do lots of reading to find out about the pros and cons of this drug and get a second,third,fourth ...opinion before I consent to participate in this study.

Will let you know of the outcome of monday's appt.

Meanwhile, here are a few sites on Dabigatran...

http://www.warfarinfo.com/dabigatran.htm

http://www.boehringer-ingelheim.com/corporate/asp/news/ndetail.asp?ID=4294

http://www.boehringer-ingelheim.ca/news_releases/2007/2007-07-11.asp

http://en.wikipedia.org/wiki/Dabigatran

http://jcp.sagepub.com/cgi/content/abstract/45/5/555

http://www.ncbi.nlm.nih.gov/pubmed/17869635

http://salesandmarketingnetwork.com/news_release.php?ID=2019423

http://asheducationbook.hematologylibrary.org/cgi/content/full/2004/1/424

http://www.blackwellpublishing.com/isth2005/abstract.asp?id=47119
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PostSubject: More details about the Dabigatran study...   Sun Jan 20, 2008 9:21 pm

RE-MEDY STUDY

PATIENT INFORMATION AND CONSENT FORM


Re-Medy: A phase III, randomised, multicenter, double blind, parallel-group active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for the secondary prevention of venous thromboembolism. RE-MEDY (study 1160.47) protocol date: 20 January 2006 (Protocol 1160.47. Original protocol: 20 Jan 2006. Amendment 1: 10 April 2006)





You have been treated for a period of 3 to 12 months with a blood thinner for a blood clot, or you are participating in the RECOVER trial. It is important that you carefully read and understand the following information about the RE-MEDY study. Please ask as many questions as you like. You should take this information home and discuss the study with a friend, family member, or your family doctor before you agree to take part in this study. Reading and signing this consent form is necessary before you can participate or before any study-related procedures are done. Participation in a clinical study is voluntary.

This study is being sponsored by a drug company called Boehringer Ingelheim. The Thrombosis Program is being paid by the sponsor to conduct this study. Any money left over after the study expenses are paid is deposited in a research trust fund (used to conduct other Thrombosis Program research).

BACKGROUND AND PURPOSE OF THE STUDY

You have been asked to take part in this research because you are currently being treated with a blood thinner for 3 to 12 months for a blood clot in one or both of your legs (known as deep vein thrombosis; DVT) and / or lung (know as pulmonary embolism; PE).


OR

You are participating in the RECOVER trial for treatment of a blood clot in one or both of your legs (known as deep vein thrombosis; DVT) and / or lung (know as pulmonary embolism; PE) and you will soon complete the study.

A vein blood clot is called a deep vein thrombosis (DVT) and a lung artery blood clot is called a pulmonary embolism (PE). DVT and a PE are collectively called a venous thromboembolism (VTE). Patients with VTE take blood-thinning medications such as warfarin (coumadin) which is given with the intention to stop the blood clot from getting bigger, stop it from coming back, stop it from breaking off and going to the lungs, and to prevent death. Certain other drugs and food can affect these medications. Therefore, frequent blood testing (INR tests, "International Normalized Ratio”) is necessary to maintain the right dose. The doctor uses the INR test results to decide how much warfarin medication you need to take. If the dose is too high, the blood may be too thin and cause bleeding. If the dose is too low it may not be enough to prevent VTE.

Dabigatran etexilate is a new blood thinning drug that does not appear to require INR testing or dose adjustments. It is an investigational drug in that it has been approved by Health Canada for use only in research studies for the treatment of blood clots.

You are being asked to take part in this study because your doctor thinks that you need a long-term blood thinning treatment as you are at risk of having another blood clot. The purpose of this study is to evaluate how well this drug (dabigatran) works and how safe it is compared to warfarin, which is the standard blood thinner for patients with blood clots.

STUDY OUTLINE

Approximately 2,000 participants in 27 countries with VTE will participate in this study worldwide (about 150 participants in Canada, and 10-15 participants at our location). If you agree to take part in this study it will involve 14 (monthly) visits to your study doctor and should last approximately 76 weeks. In exceptional cases, the study could last longer than 76 weeks, if ongoing events at the time of the last study visit require further follow up. If needed, your study doctor may also ask you to come for an unplanned study visit. Standard of care visits would be every 6-12 months.

PROCEDURES

This study has 3 parts: Screening Period, Treatment Period and Follow-Up Period.



Visit 1 (Screening Period)

After signing the consent form, the following tests and procedures will be done. You will also be provided with an “emergency” card. This is the size of a credit card and should be carried on you at all times. It provides essential information about the study along with contact details.

Review of your medical history, any current medications you are taking or have taken within the last 2 weeks
Physical examination
Electrocardiogram (or ECG - measures the electrical activity of the heart);
Blood (about 2 1/2 teaspoons or 12.5 mls) will be taken for routine testing;
Either blood or urine pregnancy test (if you are a woman of childbearing potential)
Baseline examination: a bilateral leg ultrasound will have to be performed before or no later than 72 hours after visit 2.
Stop current blood thinner. If you are in the RECOVER study, see additional information below*.
Regular INR testing will be started until the end of the study. INR will have to be tested daily, as soon as the INR value is 2.3 or less, Visit 2 will occur. This could happen the same day as Visit 1


* Visit 1 (Screening period) (for patients included in the RECOVER Study)

This visit will be done after Visit 9 of the RECOVER Study


For patients entering RE-MEDY from the RE-COVER Study:

Patients who enter RE-MEDY fro the RE-COVER study have a 1 in 4 chance of switching from dabigatran therapy in RE-COVER to warfarin therapy in RE-MEDY. Gor these patients, it will take some days for warfarin to attain an optimal therapeutic effect. It is thought that this will not have any consequences on the risk of VTE recurrence, as this sub-optimal therapeutic period will last only a few days, and you have already received 6 full months of treatment. Your daily risk of recurrent blood clot is low.

Warfarin/warfarin placebo will be started using the RE-MEDY study drug kit when you are rnadomised to the RE-MEDY study.

However, your investigator will evaluate your risk of VTE recurrence and may propose that you receive “bridging therapy” with an injection (subcutaneous, under the skin) rapid onset anticoagulant, called Low Molecular Weight Heparin (LMWH) for a day or so until the warfarin becomes effective. While receiving LMWH, the dabigatran/dabigatran matching placebo capsules from the RE-MEDY study kit will be held.

Bridging therapy with LMWH will, according to local medical practice, be started 12-24 hours after your last dose of dabigatran/dabigatran matching placebo taken in the RE-COVER study.

Once your INR is in the therapeutic range of 2.0 to 3.0, treatment with LMWH will be stopped, and you will start taking dabigatran/dabigatran placebo capsules fro the RE-MEDY study kit.

Day 2 (visit 2) (Treatment)

If you continue to qualify at visit 2, you will be randomly assigned by chance (like tossing a coin) and with equal probability of 50% to one of the two study treatments; warfarin (tablets) and a dabigatran placebo (capsules) or dabigatran etexilate (capsules) and a warfarin placebo (tablets). (A placebo contains no active ingredient) Neither you nor your study doctor will know which treatment you will receive (however this information will be available in case of an emergency) – this is known as a “double blind” study design.

The following will be done during this visit:

Review of any changes in how you have been feeling since your last study visit (including any medications that you may have taken);
Dispensing of medication kits.
Start treatment with warfarin tablets and dabigatran capsules, on the same day if INR<2.0, the day after if the INR is between 2.0 and 2.3.

Visit 3 (Telephone interview)


Review of any changes in how you have been feeling since your last study visit (including any medications that you may have taken). This telephone interview should last between 10 and 20 minutes.


Monthly visits (visit 4 – 9)

Each of these visits will be about 30 days apart. At each visit you will have the following done:

You are asked to return all medication kits you received at the previous visit.
Review of any changes in how you have been feeling since your last study visit (including any medications that you may have taken);
Physical examination
Blood (about 2 1/2 teaspoons or 12.5 mls) will be taken for routine testing;


Visit 10-13

Each of these visits will be about 3 months apart. The visits will be conducted as visit 4-9.

Visit 13 (End of treatment at 18 months)

You are asked to return the remaining medication kits and the patient diary
You will have blood taken (about 2 ½ teaspoons or 22.5 mls) for routine testing;
You will also have a review of any changes in how you have been feeling since your last study visit (including any medications that you may have taken).
You will have a physical examination and pregnancy test (if you are a woman of childbearing potential).
Visit 14 Follow-up Period (End of study at 7 months)

The following will be done at visit 14:

You will have an ECG taken;
Blood (about 2 1/2 teaspoons or 12.5 mls) will be taken for routine testing;
You will also have a review of any changes in how you have been feeling since your last study visit (including any medications that you may have taken);
Physical examination.
Your participation in this research study is considered completed after this visit, unless there are any ongoing adverse events that need to be followed up. If that is the case, your study doctor will make a new appointment with you.

At the end of the study or if you stop taking study medication during the study, your study doctor will discuss the benefits and risks of the treatments currently available on the Canadian market for the prevention of VTE.

In this study, on average approximately 10-15 tablespoons (150-225 mls) will be collected in total.

Additional visits for INR tests

Warfarin is a blood thinner and repeated blood testing (INR) is required to find and maintain the right dose. These visits will be frequent initially (every 1-3 days) and then decreased to once every 1-4 weeks depending on the results.

In this study, INR testing can either be performed using a portable ‘point of care device’ (PoC) which require 3 drops of blood from your finger per measurement, or by traditional testing which requires approximately 1 teaspoon of blood per measurement. INR testing is only used to adjust warfarin doses, it is not needed for dabigatran, however, in order to ensure that neither you nor anyone else involved with the conduct of the study knows whether you are being treated with warfarin or dabigatran, all study patients, regardless of treatment, will receive INR testing. Your INR results will be “coded” so that no-one involved with the conduct of the study will know your real INR results. However the “coded” results will be decoded by a central laboratory, who will then instruct your study doctor how to adjust your study medication. This will ensure that if you are receiving warfarin, you will continue to receive the correct dose.
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PostSubject: Part deux... (Dabigatran)   Sun Jan 20, 2008 9:22 pm

Additional procedures and visits for unexpected events:

If you experience symptoms ( new leg pain or swelling, chest pain shortness of breath) that suggests a new blood clot (VTE) recurrence during the study, examinations to confirm the event need to be performed (as is usual standard care); in case of DVT: an ultrasound and/or venography of the leg(s); in case of PE: a lung scan, and/or pulmonary angiography. After confirmation of the event, the study medication will be discontinued and, if required, standard anticoagulant therapy given.

In case you experience symptoms of a new (recurrent) VTE, a major bleeding event or an impairment of renal function, or whenever study medication is stopped early, additional blood samples will be taken to determine dabigatran blood levels, and for blood clotting tests. Should any of these events occur, they will be treated according to local procedures at the hospital.

In case of any bleeding, you will also have an additional blood sample taken (about 1 teaspoon or 5 ml) to determine your level of red blood cells.

Finally, blood samples might also be drawn if you experience any increase in your liver function tests (testing how well your liver is working). If liver values exceed pre-specified limits, further examinations (e.g. laboratory and imaging techniques) may also become necessary.

PATIENTS RESPONSIBILITIES
It is very important for you to return for every study visit and bring your supply of study medication (including empty bottles) with you. Do not discard any study medication or bottles. You should also record the start and end time of use of each medication kit in the patient diary, and bring it to the study visit as described.

You should store your study medication in the box (kit) and bottles that were given to you away from the reach of children or those who are not able to read and understand the label. Keep the medication at room temperature (not above 25°C = 77°F), out of direct sunlight, and keep the lid of bottles tightly closed (since the study medication is sensitive to moisture in the air).

You should take your study medication as instructed, and at the same time(s) every day (each kit contains trial medication sufficient for 33 days of treatment). Do not take the study medication out of the bottle until it is time for your next dose.

The dabigatran etexilate capsules should be taken with water and swallowed whole. Do not chew, crush, open, or break the capsules. You can take them with or without food. You should not skip any doses, but if you do, just take the next dose as scheduled and do not take two doses at one time. If you have any doubts you should contact your study doctor.

The warfarin tablet(s) should be taken with water and not chewed. You should take only the number of tablets instructed by the study doctor. If you forget to take a dose, you should take it as soon as possible on the same day. Do not take two doses at one time. If you have any doubts you should contact your study doctor.

You should not take any medications, including prescriptions, over-the-counter medications or herbal products, unless the study doctor or staff says that it is OK. If you experience any unusual symptoms, it is important for you to contact your study doctor as soon as possible.

RISKS, SIDE EFFECTS AND/OR DISCOMFORTS
Your participation in this research study may involve risks that are currently unforeseeable (unable to predict) or unknown. If you experience any unusual symptoms, it is very important for you to contact your study doctor as soon as possible as you may need medical attention. ******************

Known risks, side effects and/or discomforts include the following:

Study Medication: Dabigatran etexilate

More than 2,400 subjects have been treated with dabigatran etexilate. Side effects that have occurred include the following:

Most common: 15% of patients had some minor bleeding, such as hematoma (skin swelling containing clotted blood), blood in the urine, bruising, longer bleeding times, throwing up or spitting up blood, bleeding of the gums, nose, or around the eyes, bleeding from the stomach, intestines or rectum. Stomach or intestinal bleeding (from gastric or duodenal ulcer) can give black tarry stool as a result of blood in the intestine.

Major bleeds requiring hospitalization are uncommon, occurring in 1-3% of patients per year. Bleeding events (major or minor) are expected side effects of anticoagulants including dabigatran etexilate, this includes bleeding events which may rarely be fatal.

Bleeding events have occurred with increasing frequency with higher doses of dabigatran etexilate. Therefore, the doses of dabigatran etexilate used in this study have been carefully chosen to offer the best likelihood of preventing blood clots with the least chance of causing bleeding problems or other side effects. The highest dose of dabigatran etexilate in this study causes bleeding at approximately the same rate as warfarin (the drug we usually use). Taking aspirin (ASA, acetysalicylic acid) at the same time as warfarin or dabigatran etexilate increases the risk of bleeding associated with both medicines.

Stomach pain or abdominal discomfort has occurred on dabigatran etexilate, in approximately 8% of patients. The frequency is increased to approximately 16% when dabigatran etexilate is given together with aspirin.

Less commonly, increases in liver function tests have occurred in previous studies involving dabigatran etexilate. These abnormalities ranged from 0.4 to 1.5% of patients. Therefore, liver function will be an important part of your laboratory work-up, and monitored carefully by your study doctor.

Rarely, gastric or duodenal ulcer associated with bleeding and black tarry stool as a result for blood in the intestine have been reported.

Comparator Medication: Warfarin (usual care)

Bleeding events are uncommon (1 to 2 %) if warfarin therapy is well controlled through regular INR testing. However, if bleeding occurs when warfarin therapy is well controlled, it can indicate the presence of an underlying bleeding condition which may require further study.

Other rare (less than 0.1 %) side effects are death of skin tissue within a few days of starting warfarin, pain, low white blood cell count with related infected ulcers in the mouth and intestinal tract, tiredness and weakness, headache, dizziness, diarrhea, stomach and intestinal upset, purple toes syndrome (painful, blue-purple colored toes), feeling cold and chills, increased sensitivity, skin rashes, hair loss, jaundice and liver dysfunction, kidney insufficiency and damage with excess water buildup and protein in the urine.

Side effects that have caused the discontinuation of warfarin are bleeding under the skin (black and blue), fever, nausea and vomiting, inflammation of the pancreas, bleeding from the nose and bleeding around the heart and lungs.

Blood Draws, Blood Pressure Measurements and ECG’s

In this study, on average approximately 10 – 15 tablespoons (150- 225 ml) of blood will be collected in total. Possible side effects from a blood draw include fainting (rare) and pain, swelling, bruising, or bleeding where the needle is inserted. There is also a slight possibility of infection where the needle is inserted.

ECGs will be recorded during the study. ECG electrodes may cause skin irritation, and pain when they are removed, especially from a hairy chest.

When blood pressure is measured the blood pressure cuff may cause some mild discomfort, bruising, or red spots on the arm.

Pregnancy Risks


If you are pregnant or planning to become pregnant, or are nursing an infant or child, you cannot take part in this study. You must be using an acceptable method of birth control now and during the study. You should discuss with your study doctor if the method of birth control you are using is medically acceptable. A pregnancy test will be done at Visit 1 to make sure that no pregnant women are accidentally enrolled into the study.

Women of child bearing potential should not take warfarin because it can pass through the placenta and may cause fatal bleeding to the fetus. There have been reports of birth defects in children born to mothers who have been treated with warfarin during pregnancy. Spontaneous abortion and stillbirth are known to occur and a higher risk of fetal death is linked to the use of warfarin. Low birth weight and growth retardation have also been reported.

The effects of dabigatran etexilate on a human embryo, fetus (unborn baby), or nursing infant are not known. In animal studies, pregnant rats and rabbits experienced toxicity due to the pharmacodynamic effect of dabigatran etexilate. If you should become pregnant during this study, you must notify your study doctor immediately. Whichever study drug you are on will be stopped.

NEW FINDINGS
If any new findings or new information is learned about this study or the study medications that may affect your willingness to continue in the study, you will be told as soon as possible.


POTENTIAL BENEFITS

There is no guarantee that you will receive any personal benefit from taking part in this study. By participating in the study you are contributing information about the study medication that may, in the future, benefit others.

ALTERNATIVE TREATMENTS
You do not have to be in this study to receive appropriate treatment for your condition. There is other treatment (low molecular weight heparin injections or warfarin tablets) available for the treatment of VTE, which you are likely currently taking. Your study doctor will discuss with you the benefits and risks of alternative treatments.


MEDICAL TREATMENT FOR INJURY

In the event of a research-related injury, you will be provided with appropriate medical treatment. You are not waiving your legal rights by agreeing to participate in this study. The study doctor, the study sponsor and the hospital still have their legal and professional responsibilities.

COST

You will not be charged for taking part in this study.

If you have any questions about your rights as a research volunteer, you may contact:


PAYMENT FOR PARTICIPATION


You will not be paid to participate in this study. Reimbursement for parking or taxi to come to clinic visits will be provided.

VOLUNTARY PARTICIPATION/WITHDRAWAL

Taking part in this research study is voluntary. You may choose not to take part or you may stop the study at any time for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care.

The study doctor or sponsor may stop study medication and/or remove you from the study without your consent for any of the following reasons: if it appears to be medically harmful to you, if you fail to follow directions for taking part in the study, if it is discovered that you do not meet the study requirements, at the discretion of the study doctor, if the study is cancelled, or for administrative reasons.

If you stop taking study medication for medical or other reasons, it does not mean that you are automatically removed from the study. Your study physician will ask you to continue study treatment once the reasons for not taking study medication have been resolved.

If you wish to permanently stop taking the study medication before the end of the study, you will be asked to return for an end of study treatment visit (visit 14). Study procedures outlined at visit 14 will be completed and if you are unable to attend, a telephone follow-up is necessary to complete the file. At that time, you must return any study medication and bottles. In addition, you will be asked to return for all scheduled follow-up visit(s). Although voluntary, these visits are strongly recommended. They are important to improve the medical knowledge about dabigatran, to assess any unknown long-term effects of the study medication and they are important for your safety. If it is not possible to return for all the study visits, your study doctor or study staff will call you or your designated contact at regular intervals (about every three or four months) to see how you are doing. The study staff is required, by law, to respect your wishes to not continue participation in this study. They can not dispense any additional study medication to you after you have chosen to withdraw from this study.

CONFIDENTIALITY

Your medical records will be treated as confidentially as possible under local, provincial and federal laws. Coded information from this study will be submitted to the sponsor, U.S. Food and Drug administration (FDA) and Health Canada (HC) and the Ottawa Hospital Research Ethics Board (OHREB). It may also be submitted to governmental agencies in other countries where the study medication may be considered for approval.

Medical records which identify you and the consent form signed by you, may be reviewed by representatives of the sponsor, the FDA, Department of Health and Human Services (DHHS), Health Canada, regulatory agencies in other countries, and the OHREB that has reviewed this research project to help ensure that the rights and welfare of the volunteers are protected and that the study is carried out in an ethical manner. Your health information will be kept confidential, unless required by law. The results of this research study may be presented at meetings or in publications; however, your identity will not be disclosed. No records bearing your name will leave The Ottawa Hospital, records will be coded with your date of birth, sex, race, initials and study number.

You have the right to check your study records and request changes if the information is not correct.
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PostSubject: Re: My story...   Mon Jan 21, 2008 6:13 pm

Jan 21/08

Had my six month post-diagnostic check-up, plus a bunch of blood tests, EKG and a medical in preparation for this drug test study I'm starting tomorrow. I talked/querried the program co-ordinator about this new drug called dabigatran (on it's third phase before it is approved by the FDA and hits the market, hopefully in 2010 if all goes well).
According to the program co-ordinator dabigatran is easy to manage (both for the patient and the medical staff) it's not a vitamine K antagonist which means no dietary restrictions, it does not need to be monitored as closely as warfarin (lot less INR tests) and is fast to get in and out of your system (12 hrs) and easier on your body,less internal bleeding as a long term user.
Had a lots of blood taken out for various tests, one was a INR of 2.0 and the program co-ordinator did one of those finger stick thingny INR was 2.3 scratch (hey, it's still in the targeted area!) cheers So I signed the consent document to participate in this study...
Starting tomorrow, I will be either taking warfarin or dabigatran. (double blind test, since I need an anticoagulant, it can't be a single blind test) I will be alternating between 8 and 9 mg of warfarin (or not Wink) daily and a capsule of dabigatran (or not Wink ) every twelve hrs.
I will have a doppler test done on both of my legs on friday (jan 25/08, 9:30 AM) as a base test.

PS. I will keep a daily journal of this study here... study

Arrow -No anticoagulants today,nothing,rien, nadda, zip.
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PostSubject: Re: My story...   Wed Jan 23, 2008 2:07 am

Jan 22/08

8mg warfarin ( 1x5mg+1x3mg) @ 6PM
1 capsules of dabigatran every 12 hrs (1 @ 6AM+ 1 @ 6PM)

So far,no noticable side effects, but the comfirmed "warfarin" is still in my system for another three days (last confirmed dosage of warfarin was
3X 2.50mg + 1X1.75mg on sunday Jan 20/08 )
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PostSubject: Re: My story...   Sun Jan 27, 2008 10:27 pm

scratch what's the date today? affraid , sorry, guess I missed a few days, I've been alternating every day
from 8MG to 9 mg of warfarin and 2 capsules of dabigatran.
Going to the hospital to get an ultrasound tomorrow and an INR, we'll see.
It has been almost a week, regarding being always tired, it's really hard to say, I have been working long hrs...
My leg has been swelling up still, (long days and lots of walking).
Wish I could know if I can have more vitamine K, I miss pigging out pig on spinach, splurging on greens...
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PostSubject: Re: My story...   Mon Jan 28, 2008 8:56 pm

-Had the Doppler test done on both my legs (DVT/right and non DVT/left) I asked the ultrasound teck how my left leg looked, she said "it's a beatifull leg". Wink
I also had a INR test, although I don't get to know what my results are, my warfarin dosage has been adjusted, last week I was alternating daily between 8 and 9 mg of warfarin, this week (starting today/monday) I'm doing 10mg, 10mg, 9mg, 9mg of warfarin and a capsules of dabigatran every twelve hrs.
Another INR on friday.
Suspect the drug company adjusts your placebo dosage sometimes just to throw you off...
So I don't know if it's warfarin or dabigatran scratch
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PostSubject: Re: My story...   Sun Feb 03, 2008 12:03 am

I have to be more consistant with this journal, sorry.
Since my last entry I have had another INR test and the results were still 1.9(second time in row...) and so my warfarin(or placebo ) was re-adjusted accordinally.
I have another INR test scheduled for tuesday (feb 05/08 )
It starting to feel like when I first started on warfarin back in july, INR test every four days or so... They don't always work with my schedule. Rolling Eyes
Feb 01: 10 mg warf
Feb 02: 10 mg " "
Feb 03: 10 mg " "
Feb 04: 9 mg " "
Feb 05: INR test
not to forget , I also do a capsule of dabigatran (or placebo) every 12 hrs.
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PostSubject: Re: My story...   Wed Feb 06, 2008 9:15 pm

Been working a lot lately... Sleep
Feb 05/08 INR was 2.9 and that is after forgetting to take a dabi capsule on sunday feb 03/08.
My dosage has not changed and will be like this until my next INR ,
feb 12/08
Had a monstrous headach last night and took 30 MG tylenol #3,
got 2 hours of sleep, but the headach was gone when I woke up. cheers
leg,as usuall swells up,out of shape and always tired.
What else can I say, but it sucks to be me!!!!
Oh, and it's winter. Mad
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PostSubject: Re: My story...   Tue Feb 12, 2008 12:59 am

What a day!!! Here's to depression.

Today I resigned from two post that I have had for the last three years. Why did I do that you may ask and what were those post?

For those who don't know, you have to understand that "I used to be an avid mountain biker"(until I was sidelined by DVT), was a rep for two non-profit organisations here in Canada. One was a National entity "IMBA Canada" and the other was a Provincial entity "ADSVMQ".Both of these organisations deal with mountain biking advocacy,since november last year I have been talking with my doc about having to stop mountain biking not because of the DVT, but because I'm a long term anticoagulant user, if not a lifer.
Extrem sports and these meds do not mix, unless you have a deathwish, which I don't btw. Looking at my options which were making a clean break from it all(ridding and the org) or just stopping the ridding would had been very hard on me, you can imagine planning all these events and not being able to participate...
Or, just taking my chances and keep on ridding and not resign...(this is not an option, had to add it in the mix).Chances of hurting myself badly and bleeding to death are very present.
Yes, this will leave an immense void in my life, but it outweighs the third option.
So yes, DVT is hard on us all,even after the initial phase of dealing with it and finding about this silent killer.
I was diagnosed last year in july so that's seven months and I'm still dealing with the repercution and I'm not done.
This next one will be a hard one for me to separate myself from, I'm the president of an organisation (another non profit org) that has built, planned, maintained and managed this mountain bike trail circuit that was just starting to see the light after taking it over from a declining org, four years ago. You could call it my baby, the first year,I was on my own then ...
Anyways, yes DVT does change somebody's life, more then you think at first, get ready for it.

The rollercoaster ride is not over, the fat lady has not sung, yet.
Sad
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PostSubject: Re: My story...   Wed Feb 27, 2008 5:23 pm

I'm on a high part of the rollercoaster ride lately, I have been feeling great, maybe I'm discovering that I'm taking dabi as oppose to warfarin, if that is the case YAY dabi!!! cheers
The other thing, last time I went to the TAT Unit for a finger stick(INR), the nurse(the supervisor of both the studies I am on SOX and Re-Medy) had a look at my leg and saw how swollen it still was, she asked me if I wanted to give the compression sock another chance (last summer I had an alergic reaction or maybe a heat rash)that was on feb 21 and only after four days of wearing the fugly sock there was an immense difference, I could actually see muscle definition as oppose to this big round sausage(that's what I found my leg looked like). What a Face
So yes, things are improving, my headspace is also better...
As you can see I do spend a lots of time on the internet, constantly searching for new articles/litterature on DVT,PE... I keep seing these American associations (NATF, NAAT, Clotcare, DVT prevent...) that are promoting public awareness on DVT I keep seing Melanie Bloom on various videos (she is really a good spokeperson for DVT, since her husband, David Bloom past away because of DVT).
BUT I NEVER SEE ANYTHING COMING FROM A CANADIAN ASSOCIATION Suspect It's like we Canadian want to keep this as national secret...? Wazzup with dat???? Suspect
I started asking around, sending e-mails to key figures in the milieu and I'm starting to get feedback and it seems that everybody is saying the same thing, "yes, you are right , nothing is done, nobody wants to step up and take the lead on this",
Well 'nuff is 'nuff, I think that SOMETHING HAS TO BE DONE, I may start my own awareness campaign, I simply have to knock at the right doors and pull the right chains, if anybody wants to get involved, now is the right time, maybe we little Canadians can get our DVT AWARENESS MONTH!!!
Let me know...
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PostSubject: Re: My story...   Sat Mar 08, 2008 9:44 pm

This rollercoaster ride looks like it's levelling and becoming a train track, things have been good physically and mentally. The swelling of my leg has gone down and is staying down, just slightly bigger then what it was before the DVT in july 07. Probably due to the dabigatran, I'm not as tired as I was when I was taking warfarin (at least I think I'm on dabigatran, only the drug co. knows) I will have to start some kind of workout to regain the muscle mass I had in that leg, the mobility is back(no swelling helps that), stairs are not an issue, like it use to be, I was always struggling up the stairs.
All and all, things have improved enormously, I just hopes it continues this way.

On the "Awareness" side, I did make contact with some key people in the milieu and we did talk about how to tackle this lack of ANYTHING in Canada regarding DVT Public Awareness. We also talked about the logistics of such an organisation, how it should be setup,who should be involved so on and so forth...
As soon as anything starts develloping, I will post it in the "Where To Go From Here" forum.
Until then,stay well.
dero
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PostSubject: Re: My story...   Sun Mar 23, 2008 4:59 pm

Wow, what a diference a drug makes. I definitally know I'm taking dabi as oppose to warf, all the side effects I have learn to hate are TOTALLY gone. I wake up in the morning rejuvenated, like the sleep I get counts, not in a fog like I was CONSTANTLY, some days it was like pea soup,I hated driving in that state, Seems my body temperature is way higher then it was, not feverish but where it's suppose to be(specially makes a dif. during this Canadian winter).
On the physical side, the swelling is almost gone and like I mentioned on previous posts, it stays down...
Overall, I'm almost back to what I use to be, just have to work on tonning and bulking a bit.
Emmotionly, I will miss MTB, it's not that bad now(it's still winter)but come springtime...
We'll have to wait and see.
Taking life day by day.
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PostSubject: Re: My story...   Mon Mar 24, 2008 9:44 pm

Dero,

What is Dabi, pardon my ignorance?

Glad you are feeling so much better. I remember being freezing cold the entire time I was on Coumadin, so I relate to what you've experienced coming off it. I am sensitive to cold anyhow (and Victoria is not tropical despite what people try to say about it), therefore the time on Coumadin was truly torture for me.

What the scoop on risks with taking Dabi (whatever that is)?

Did you ever get a copy of the magazine article that you were interviewed for? I'm sure you would have posted a link to it if it was available by now.

Glad to see this forum is slowly building, as is my May-Thurner Syndrom forum...it takes a lot of time and patience, but the rewards of providing such a supportive place for people to meet and chat far outweigh the effort and patience required.

-Diane
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PostSubject: Re: My story...   Wed Mar 26, 2008 3:59 pm

Eh Diane,
How have you been lately? Yes more people are joining the forum and yes I understand exactly what you mean when you say "it takes a lot of time and patience, but the rewards of providing such a supportive place for people to meet and chat far outweigh the effort and patience required." Plus I would had loved to know of somewhere like this to go when I was originally diagnosed.

As for dabi, (* see http://en.wikipedia.org/wiki/Dabigatran*)
it`s real name is dabigatran etexilate which is another anticoagulant that is on it`s third phase(as a new drug before being accepted by the FDA).
-not a vitamine K atongonist.
- no monitoring need
-takes 12 hours to get in your system and 12 hours to get out of your system (renal way)
- for long term users, it is not as hard on your liver compare to warfarin.
-some people are stilll leary(doctors and out patients) because warfarin as it is, has been around since 1952(if I recall correctly) and dabi has been under study for 10 around years.(the three mandotary study phases)
so yes the long term effects, are not all known...

But what I like is that 2 weeks after I started on this study I re-discovered "life" or as close to what I knew it as, well without the biking, it`s still an anticoagulant.
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PostSubject: Re: My story...   Sun Apr 27, 2008 7:41 pm

To let everybody know how things are...
Had bloodwork last thursday and it was 2.0 (doing my happy dance)
Blood pressure and heart are good, Angele the study coordinator tells me that I have a heart of a 35 year old man, if only I would have the leg of a 35 year old man to go with that. (sigh...)
Anyways, spring is here and the period I have been dreading is here, I have been busy with work so no time to miss MTB, 'cus this would be the time I would start hitting the trails...
We'll see.
SO, physically and mentally things are good!!!
See if Ican keep it that way...

*Have some meetings coming up, with some important people regarding the Canadian DVT association, I'll let you know if and when anything developpes...
Be well.
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PostSubject: Re: My story...   Fri May 23, 2008 12:00 am

Well another good INR, 2.1 today, I keep doing my happy dance,seems that 10/10/9/10/10/9/10 is the dosage that Boehringer(drug company that is doing this study) likes to see, even though I'm doing warfarin placebo(sugar pill).
Work has been extremely busy lately, so I have not been able to further my quest in starting this Canadian DVT public awareness campaign.
As soon as something does happen, you will be the first to know of the details...

Be well.
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PostSubject: Re: My story...   Fri May 30, 2008 8:19 pm

Ok, so here I am at the TAT Unit for a 9 month check up,kind of appt that should last 15, 20 minutes talking with my doctor(hemaetologist) but in the last few days, I have been having these chest pains and shortness of breath(yes the PE alarms are ringing in my head),so I mentioned it to Dr. Martha ,stetoscope to lungs breath in ,out... She tells my Dr.(Dr Forgie) and in comes Dr. Forgie with a puzzled look on her face, querries me and tells me that I'm on my way to the lab for a CT-scan and d-dimer test... First time I had a CT-scan,that leaves a bad taste in your mouth, (yuk!!!) and that is so weird that warm feeling that travels through your body and the speed, anyways the tests came back, d-dimer NEGATIVE and ST-scan NEGATIVE what a relief!!!!
YAY!!!!! Leaving the TAT Unit 4 hrs later with PE out of my mind, need to setup an appt with my GP for a physical, need to find out what this pain is,must have known... a month before I stop working for the summer. Rolling Eyes
Aside from this day at the TAT Unit, the leg is stable, it only swells when I work long days, standing on it. Wearing the fugly (compression sock) really helps enormously.
Last week's INR was 2.1
So overall, all is good.
I'm alive and I can walk, that's what counts.
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PostSubject: Re: My story...   Thu Jun 19, 2008 5:12 pm

As if...
DVT itself is not enough to worry about on a daily base, sunday morning, as I entered in my bath tub I took a spill and slammed my DVT leg on the edge of the tub. It felt like I had just gotten hit with a 2X4 just bellow my right knee, the bump from it was like I had two knees on that leg...

So like a good boy, off to the ER I go to get it checked out, after bloodwork(2.3 INR), xrays(no broken nor chipped bones) and what else? 7 hrs later I left the hospital with a bottle of pain killers(well a script for it) and a pat on the back for being a good DVT patient and a clean bill of health, oh and a THROBBING leg and a bruise that is getting bigger as the day goes by...

PLus a week off from work, YAY!!!!! (note from the ER Doc)

Oops, maybe I should not be so happy ...

What's next???

PS because of the swelling and pain, I cannot wear the FUGLY, see what the study co-ordinator says.



I'll be ok, scratch I think...


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PostSubject: Re: My story...   Thu Jun 19, 2008 5:16 pm

As if, part deux...

Thursday, June 19, 2008

It continues...

So after getting that bump below my knee on sunday (see my previous journal entry)

I had an INR appt. today and I told the study coordinator (Nurse Practionner) that I would like to get my leg looked at, appt set (9am this morning) and as soon as I walked in her office, her jaw dropped, my leg (below the knee) is the same size it was when I was originally diagnosed last aug, so she was concerned...She sets an appt with my Hemeatologist and as soon as she walks in the room, I see concern on her face.

INR is 2.3 and I had a Doppler done, everything was negative, but the sweling is cause mainly from a blood accumulation (hematoma )because I am on anticoags it is more prominent and if kept on anticoags, it would take forever for it to heel.
SO...
I get a week off of anticoagulants and have another appt next thursday for another assessement of the situation.

What this all means is that if I'm on Dabigatran, it will take 12 hrs for it to be out of my system or if I'm on warfarin it will take 7 days.

Yes I say "if" I personally I think that I'm on dabigatran, but others think that I'm of warfarin... scratch

So...

I have another appt. next thursday, we'll see.


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PostSubject: Re: My story...   Sun Jun 22, 2008 2:39 pm

So, my leg is sweeling everyday and really aches(throbbing pain) been off of the anticoags since last thursday.
Weird sensation(mentally) while you are on anticoags, you wish you did not have to be, while you are off of them, you know that you are at risk for cloting, maybe I'm just a tad paranoid, but it's still there... (some catch 22 eh?) scratch
But, I have a good medical team and I know that
THEY KNOW WHAT THEY ARE DOING!!!
But that does not take away this paranoia. Suspect
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PostSubject: Re: My story...   Thu Jun 26, 2008 4:25 pm

Ok, so I had my follow up today, expecting to see my doc and that she would say " that leg looks good and back on the anticoags you go" well it did NOT happen entierly that way, she did say that the swelling had gone down BUT, that I had developped a skin infection on my lower leg(knee to ankle) Mad ( I thought it was the bruising colors, because along with the red there is yellow and purple, like I said it felt and looked like somebody had hit me across the leg with a 2X4 or a baseball bat ) and that she will put me on antibiotics for a week and that I am to see her in teo weeks. She will keep me off of anticoags until then.(antibiotics and anticoags do not mix).
She also told me that Imay not have to go back on anticoags, if I do I will have to start the whole process from scratche, meaning Framin self injections(Low Molecular Weight Heparin) and warfarin until I reach a therapeutic level (between 2.0 and 3.0) and from there go back on the Dabigatran Study...
to be determined in two weeks.

What else can happen??? scratch No
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