ClotCare

Research Company Seeks Patients who Have Had a Leg Blood Clot (deep vein thrombosis or DVT)

Henry I. Bussey, Pharm.D.

Qessential Research is a research company that has asked ClotCare to help make individuals aware of a survey research project that they are conducting.  This is an industry-sponsored study, ClotCare does not know what company is sponsoring the study and ClotCare is neither supporting or recommending the study.  ClotCare is simply acting as a conduit to help potentially interested patients to be aware of this study.  The information below was provided by Qessential Research.

“Qessential Research is holding confidential interviews with individuals who have been diagnosed by a physician with blood clots in the leg, also known as Deep Vein Thrombosis. We are hoping to learn about your experience with this condition.

Who:  Men and women who have been diagnosed by a physician with Deep Vein Thrombosis

What:  Participate in a confidential interview to discuss your personal experience with DVT. The discussion will last about 60 minutes and you will receive $100 for your assistance.

When:  Interviews will be held in June, at a time convenient for you.

If you would like to participate or would like more information, please call Deborah Booker at 1-800-932-4249 or via email at Deborah@QMMR.net.

As a professional firm in the medical industry, we understand privacy rules and do not give out any information about anyone involved in our studies. We do not ask for any information regarding patients’ personal medical situation nor are we providing any information about drugs, therapies, or any other promotional information.”

An Update on Testosterone Supplementation and Venous Thrombosis by Charles J. Glueck, M.D.

(with limited edits by Henry I. Bussey, Pharm.D.)

Editor’s Note #1: Charles J. Glueck, MD of the Jewish Hospital in Cincinnatti has shared with ClotCare his work on the relationship of testosterone supplementation and venous thrombosis and osteonecrosis (clotcare.org/testosterone_factor_v_clot_risk.aspx and clotcare.org/dvt_pe_testosterone_women.aspx ). He has provided us with an update on this topic.  Dr. Glueck also offers his services at no cost to ClotCare users who have experienced blood clots while using a testosterone supplement.  You may contact him at cjglueck@mercy.com or sonar16@gmail.com

Venous thromboembolism (VTE) includes blood clots in the legs (known as deep vein thrombosis or DVT) and blood clots in the lungs (known as pulmonary embolism or PE). Whether testosterone supplementation therapy (TT) increases the risk of VTE, heart attack, and/or stroke remains at least somewhat controversial.  Earlier work (cited above in the editor’s note #1) has suggested that TT, when administered to individuals with conditions that predispose them to clotting, does indeed carry a substantial risk of VTE.  The information reviewed below provides further support for this position.

Martinez and colleagues recently examined the relationship of TT and VTE in a population-based case-control study of 9,215 patients with confirmed VTE (DVT and PE) compared to 909,530 age matched controls from a source population of more than 2.22 million men.1 Three testosterone exposure groups were identified: (1) current TT treatment (subdivided further by those with a duration

In our study of 67 men with VTE events while on TT, like Martinez and associates, we observed a peak VTE event rate at 3 months, with 60% of thrombotic events occurring within the first 8 months after starting TT.2, 3 The peak of VTE events around 3 months 1 and subsequent decline may reflect the early depletion of susceptible patients with familial or acquired thrombophilia-hypofibrinolysis4 where TT interacts with procoagulants to produce VTE. 3  Such “depletion” of susceptible patients from the group over time would leave a pro-coagulant-winnowed residual group with progressively fewer and fewer susceptible individuals over time.  Such an effect would yield fewer and fewer VTE events over time.  In other words, those individuals at risk of clotting with TT tend to have their VTE events early in the course of therapy and are removed from the pool of study patients so that the continued follow-up of the remaining patients may not show a significant risk of VTE.  This effect may explain why cardiovascular events – but not VTE events – were increased with TT by injection in the study described in the editor’s note #2 below.5

Editor’s Note #2:  TT may be administered by injection, topical gel, or topical patch. The injectable form is thought to provide higher peak levels of testosterone while the topical preparations provide lower but more sustained concentrations. To assess the safety of these formulations, Layton and colleagues performed a retrospective study of 544,115 TT users.  Among this very large group of TT users, 37.4% received injections, 6.9% used the patch, and 55.8% used the gel formulation.5  It is important to note that there was not a non-TT control group.  The risks (reported as hazard ratios and 95% confidence intervals – or CI) were higher for those receiving TT by injection.  When compared to those receiving gel TT, the injectable group had hazard ratios of 1.26 (CI 1.18 – 1.35) for cardiovascular events (ie, heart attack, stroke, and angina), 1.16 (CI 1.13 – 1.19) for hospitalizations, and 1.34 (CI 1.15 – 1.56) for death.  The hazard ratio for VTE, however, was not increased (0.92, CI 0.76 – 1.11).  The event rates in the small portion of patients who used the patch, were virtually identical to the rates seen with gel use.  Although the retrospective nature of this very large study weakens the findings, one might well conclude that the gel or patch may be safer forms of TT.  It is important to note, however, that efficacy was not evaluated in this study and that one cannot draw any conclusions about the safety of these agents vs. no TT from this study.

References

  1. Martinez C, Suissa S, Rietbrock S, Katholing A, Freedman B, Cohen AT, et al. Testosterone treatment and risk of venous thromboembolism: population based case-control study. BMJ. 2016; 355: i5968.
  2. Glueck CJ, Lee K, Prince M, Jetty V, Shah P, Wang P. Four Thrombotic Events Over 5 Years, Two Pulmonary Emboli and Two Deep Venous Thrombosis, When Testosterone-HCG Therapy Was Continued Despite Concurrent Anticoagulation in a 55-Year-Old Man With Lupus Anticoagulant. J Investig Med High Impact Case Rep. 2016; 4(3): 2324709616661833.
  3. Glueck CJ, Prince M, Patel N, Patel J, Shah P, Mehta N, et al. Thrombophilia in 67 Patients With Thrombotic Events After Starting Testosterone Therapy. Clin Appl Thromb Hemost. 2016; 22(6): 548-53.
  4. Miettinen OS, Caro JJ. Principles of nonexperimental assessment of excess risk, with special reference to adverse drug reactions. J Clin Epidemiol. 1989; 42(4): 325-31.
  5. Layton JB, Meier CR, Sharpless JL, et al. Comparative Safety of Testosterone Dosage Forms. JAMA Intern Med. 2015:175(7):1187-96

Seeking Patients Taking Warfarin (Coumadin) for a Brief Survey

Henry I. Bussey, Pharm.D.

Are you taking warfarin, have you ever taken warfarin, or have you been the care giver of someone taking warfarin?
Can you spare 5 minutes to provide information about your warfarin experience?
Joshua Wright, a current warfarin user, has developed a survey to find out the needs of the warfarin community based on individual experiences. From the survey, Joshua hopes to create a tool that will help patients better manage their daily needs and the challenges associated with warfarin use. The survey takes about 5 minutes and will ask about your experiences as a current or past warfarin user, or as a care giver of someone taking warfarin.
You can take the survey at HealthyINR.com or https://www.surveymonkey.com/r/ClotCare
Please address any questions to Joshua Wright at HealthyINR@gmail.com.
Joshua’s Story: Joshua has been taking warfarin since July 2016. As a 26 year old law student, he is hoping to find some normalcy with this life-long, but life-saving, medication. Since starting the medication, he has noticed many challenges faced by warfarin users, especially for individuals with other ailments. His irregular dosing schedule was so hard to manage that he changed it to an easier-to-manage daily dosage without his doctor’s approval — He believes that no warfarin user should feel the need to do that. He has also struggled with managing his diet, which is supposed to be low in sodium and consistent in vitamin K. His hope is that his survey can find a solution to the many problems that exist for more people than just himself and build a strong community of support.

Looking for Patients in New York City Area for a Nov. 29, 2016 Survey Research Project.

If you have experienced a deep vein thrombosis (DVT) or pulmonary embolus (PE), a survey research company may be interested in talking with your in New York City (NYC).  This in-person market research study is taking place in NYC on Tuesday, November 29, 2016.  The compensation for those who qualify for the interview is $200 for a 90 minute interview.  If interested, contact Carol Wager at carol@pharmafieldwork.com or call 732-662-4539.

Note: ClotCare is simply passing on information regarding this study.  ClotCare is not affiliated with the study, has not reviewed or approved the survey, and we do not know which company is sponsoring the survey.

 

The Thrombosis Research Institute Request Clinician Input Regarding Thrombosis and Cancer

Below is a letter received from the Thrombosis Research Institute in London asking for clinicians involved in this area to help with a global survey.

Dear Dr. or Professor:

I am writing to request your participation in the Fundamental Research in Oncology and Thrombosis, Frontline2 survey.

The understanding of best practice for preventing and treating thrombosis in cancer patients has evolved significantly over the last decade, but variations in practice still persist. The aim of this research is to describe the evolution of clinical understanding in this area since the first FRONTLINE survey in 2001, and also to highlight variations in care, nationally and internationally.

Frontline2 is a global survey, designed by leaders in the field who as an expert steering committee provide global leadership for this important programme. It is funded by an unrestricted grant from Bayer Pharma AG. The survey will collate the views of oncologists, haematologists, surgeons, radiation oncologists and members of the palliative care team who are responsible for treating cancer-associated thrombosis. The work is sponsored and coordinated by the Thrombosis Research Institute (TRI) in London (www.TRI-LONDON.AC.UK).

Why you should take part
The value of this survey lies in achieving as large and as representative a sample of clinicians as possible to generate new insights into this important clinical problem, and to help resolve unanswered questions as well as potentially stimulating further research.

By giving a few minutes of your time to complete the questionnaire, you will provide crucial information to help meet these goals.

How you can contribute
Please complete the survey via our dedicated website frontline2.tri-London.ac.ukwhere you can also find more information about us and the study. The survey will also be available in multiple languages

As a thank you for your help in completing the survey, you can download from our website, an educational slide set prepared by the TRI. The goal of the slide series is to support the continued professional education in the field of venous thromboembolism and in particular cancer-associated thrombosis. In addition, all participants in the study will be granted first-hand access to the FRONTLINE 2 results once published.

I thank you in advance for your support and collaboration on this important piece of research.

Kind regards

Professor the Lord Kakkar
Chairman of the Steering Committee for
The Fundamental Research in Oncology and Thrombosis (Frontline2) study

THROMBOSIS RESEARCH INSTITUTE
Emmanuel Kaye Building
Manresa Road
London SW3 6LR

Support ClotCare for Free and More

ClotCare does NOT receive industry support and is dependent, therefore, on donations to cover the expenses of this service.  The following are some options for helping to support this service.

Because the two biggest shopping days of the year are upon us, here is a way that you can support ClotCare for free:

Support Charity While Holiday Shopping

Actually, any time that you shop using Amazon can generate free support for ClotCare.  Just go to smile.amazon.com and the instructions will tell you how to set up an account and select the charity of your choice (hopefully ClotCare) and then any time you shop through smile.amazon.com, Amazon will donate 0.05% of your purchase to ClotCare (or whatever charity you select).

If you would like to support ClotCare at a level above that of 0.05% of your amazon smile purchases, then here are two other options.

The first option is through the “Giving Tuesday” (following Black Friday and Cyber Monday) on December 1, 2015.   This is an event in which Razoo.com facilitates fundraising for tax exempt charities.  The link below has a short video about ClotCare, a mission statement, and a “Donate” button: https://givingtuesday.razoo.com/story/Clotcare

The second option involves simply visiting the ClotCare Website at http://www.clotcare.org and clicking on the “Donate” button.

Thank you, in advance, for supporting the ClotCare Online Information Service!

Heather’s Story: When is Pneumonia not Pneumonia

[Editor’s note:  ClotCare, from time to time, will post stories from individual patients who want to help raise awareness of clotting problems by sharing the details of their experience.  Heather’s story is very similar to what happened with a female student at the University of Texas a few years ago in that both presented with the “classic” features of a pulmonary embolism (PE) and both were diagnosed as having pneumonia.  In Heather’s case, after two emergency room visits, an ambulance transfer to a teaching hospital, and two days’ of hospitalization, the correct diagnosed of a PE was made.  Unfortunately, the UT student who was treated for pneumonia died from her unrecognized PE after repeated visits for her “pneumonia”.  According to Heather’s story, appropriate treatment was delayed until the next day even after the correct diagnosis was made, the probability of a deep vein thrombosis (DVT) in her leg was not evaluated, graduated compression stockings were not prescribed and a evaluation for a clotting disorder was not considered.]

Hi, my name is Heather. I am 18 years old and I’ve just graduated High School. In June of 2015, I decided to try to begin my Nursing career by taking CNA classes. I was quickly hired on at a local nursing home facility. A month went by, and I did not like my job as much as I thought I would have. I left the facility. A week after leaving my job, I began to have sharp pains in my right thigh and hip. I figured I had pulled a muscle due to transferring residents at the facility, so I tried to rest. The next day, the pain had moved to my right side just underneath my rib cage, and also to my right shoulder blade. It was painful to breathe, so my Mother and I decided to take a trip to the Emergency Room.

After being given a room and 2 liters of intravenous fluids, it was time to get a CT scan done. I had to move off of my bed and into another. Laying straight down, I could not get a breath of air whatsoever. I was glad to have the CT scan done and over with, believe me. I was rolled back into my room, and waited for the results of the scan. A doctor came in a little while later, and explained that I have pneumonia in my right lung, as well as gall stones. He also had told me, surgery would be scheduled later that week to have the gall stones removed. I was sent home with antibiotics and a rescue inhaler and was told to take Ibuprofein as needed. The next day came, and the pain only got worse. I was unable to talk, walk, or breathe without being in severe pain. I wasn’t getting enough oxygen and I felt as if I was about ready to pass out. My parent’s rushed me back to the Emergency Room.

After being wheeled into the hospital, my vital signs were taken and I was quickly given an observation room. My heart rate was 167, my oxygen in the 70’s. I was gasping for air. The nurses put a cannula in my nose and set the oxygen dial to 2 liters per minute, gave me a small dose of Morphine and also gave me intravenous fluids. They patched stickers all over my body, getting me ready for an EKG. I texted my boyfriend and let him know what was going on whilst in the midst of all this, and he was in the observation room with me in a split second. After the nurses had left, I just stared at my parent’s and my boyfriend, Ricky. He layed his hand on mine and started to tear up when he said, “I hate seeing you like this, I don’t like it, babe.” I started to tear up too. I didn’t like it either. I could only imaging the things that were going through his head at the moment.

An hour or so went by and my heart rate was still very high and my oxygen level very low. The doctor decided I needed to be sent to UK Hospital here in Kentucky for further observation. Ricky and I both started crying, while my parent’s reassured us that everything was going to be okay. Forty-five minutes later, two unfamiliar men with a stretcher were standing right outside my door. “You ready?” They asked me. I didn’t say anything back to them. They raised my bed, and transferred me onto the stretcher. I was wheeled out into the hallway, where I kissed my boyfriend and parent’s, and told them I would see them in a bit.

I had never been in an ambulance before, so I had no clue what to expect. Once I was in the ambulance, one of the men introduced himself to me while hooking me back up to some crazy contraption. I had decided I would try to sleep on the way to Lexington, because I live nearly two hours away. I didn’t want to worry that I would stop breathing in the ambulance, due to lack of oxygen. I didn’t want to think about what would happen to my family if something horrible happened to me. So I slept as best as I could on a bumpy trip. Waking up here and there, hoping Ricky and my parents were behind us.

Once I arrived at UK, I was placed in another observation room. Immediately being hooked up to oxygen and being put on another 2 liters of intravenous fluids. Five minutes later, I could see my parents and my boyfriend walk through the Observation Rooms’ entry. I waved at them, and they all came running towards me. They hugged and kissed me, and asked if I were okay. I told them, “I’m tired, but I’m alright.” Besides, it was two in the morning when I arrived at UK, who isn’t going to be tired? Everybody sat beside my bed, keeping a close eye on me. It was around eight in the morning, a nurse came in my room to get me for an X-ray. I had to stand for the X-ray and take deep breaths, which was very painful for me. I was just glad to be sitting back down in the wheelchair when we were finished. Once getting back to the room, my parents explained to me that they had to get back home and get some extra clothes and sleep a little longer while Ricky stayed with me. He had told me the only way he is leaving the hospital is with me.

Ricky took such good care of me while my parents were gone. Helping me get comfortable in my bed, giving me sips of Sprite when I needed it, getting a nurse when I was in pain, etc. A nurse even brought in a new bed big enough for the both of us to sleep in, how sweet! I know it must not have been easy running on little or no sleep, but he did it because he loves me. That evening when my parents were back, it was time for another CT Scan, which I dreaded. I already knew laying straight down, was going to be tremendously painful. Thankfully, it was quick and the technician helped make me comfortable while on the bed. Another day went by with nothing but continuous oxygen, intravenous fluids and pain medication. One early morning I was woken up to have an ultrasound of my gallbladder done. The technician had seen plenty of gall stones in my gallbladder, which wasn’t what I wanted to hear. A team of surgeons came into my room later that day to talk about surgery options and what not.

The very next day, a doctor came into my room, and sat down in a chair next to me. He shook my hand, and asked how I was doing that day. He introduced himself and started to explain to me that he had looked over my X-ray and CT Scan a countless amount of times. He said to me, “I found it very odd, to see a healthy 18 year old girl on oxygen. And even crazier that when the cannula is taken out your oxygen level drops. So I decided to dig a little deeper.” I began to think to myself, “Is this what we have all been waiting to hear?” He continued explaining to me, that he had found a Pulmonary Embolism in my right lung, otherwise known as a blood clot. We were all shocked. “Primarily, we believe this is from your birth control pills. Even though you had only been taking them for three months, you are the unlucky girl that actually developed one of the risks your doctor mentioned before you started taking the birth control.” My Mother and I looked at each other, confused. We told him we didn’t know that blood clots are a risk in girls my age. The warning label clearly says, “Blood clots are a risk for women over the age over 35 and who smoke.” I wasn’t either of those. We were all appalled. He had mentioned that the surgery was off. The pain I was feeling was not gall stones, it was the lung damage that had already been done. Before leaving my room, he told me that he was going to put me on Lovenox shots twice a day along with Coumadin once a day.

That next morning I started taking the Lovenox and Coumadin. I’m not too big of a fan of the Lovenox. I hated the ugly bruises I was left with. However, it seemed like I was breathing a little bit more easily than I was before, and I was sleeping better, too. I remember waking up in the middle of the night and looking over at Ricky thinking just how good a man I have. I know he probably had better things to do, but I’m glad he chose to stay with me and be there for me. And there were also my parents. Seeing them sleep in rock hard chairs made me feel so bad. I felt like giving them my bed, and letting me have the chair. I could tell they were uncomfortable and not really sleeping the best and it bothered me.

The next day, I was finally discharged, woo-hoo! My little brother showed up to see me that day, I missed him terribly. He gave me a ton of love. All I could think about was how happy I was to get home be in my very own bed in my very own house. The nurse had come in my room with some discharge papers, and a box. “This is your Lovenox shots, which will be given once every twelve hours.” She then proceeded on teaching my boyfriend and family on how to give the shots. “It’s not too bad after you get used to giving them,” she said. “Now, I’m gonna bring in your portable oxygen tank and get you hooked up on that so we can get you out of here and ready to go home!” I was more than ready.

It was time. I was hooked up to the oxygen tank, and in a new change of my own clothes. I stood up and sat in the wheel chair. The nurse took me outside where Ricky, my Mother and little brother and I waited on my dad to pull our vehicle up. We all got in and were on our way home, finally. Ricky held my hand on the way home, while I tried to catch up on some rest. Once arriving at my house, I immediately fell asleep. Ricky woke me up and said, “Baby, I’m gonna head on home and catch up on my sleep, too. I’ll be over here to see you tomorrow, I promise.” He then kissed me and left. I fell back asleep.

I am now one month in my recovery. I am doing so much better and feeling so great! I am off of the continuous oxygen. I only use it as needed, if that. I am also off the Lovenox shots, hooray! I still take Coumadin once a day, and have my INR’s done twice a week for safe measures. I’ve lost a total of 16 pounds. Surprisingly, I feel no more pain! My oxygen level stays around 98-100. My primary doctor estimates that I will be on Coumadin for about six more months, which is awesome! I am a blood clot survivor and I am proud. Having this illness has made me think a lot. My advice to you is, cherish every moment you spend with your loved ones because you are never promised tomorrow. Also, please never ignore any weird or odd symptoms you may be feeling or having, it may cost you your life. I’m so happy I could share my story, and maybe help other girls out there my age to not feel so alone. I am blessed!

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