Thursday, January 22, 2009

Research Study of Blood Thinners

When I met the orthopedic surgeon last Tuesday he mentioned I could take part in a double-blind research study of a new drug, a blood thinner. He added that this drug is, "not approved by the United States Food and Drug Administration." Not yet, at least. It will be compared with a drug that is approved by the FDA for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after knee replacement surgery.

He gave me a 14 page contract-like legal document -- an Informed Consent Form -- and asked me to read it and decide, by the time of my pre-op interview at the hospital, if I would take part.

I have decided not to participate. The study appears to require a lot of followup visits and some tests that sound intrusive and stressful. Lots of visits to medical offices.

Am I expected to participate? I feel awkward turning it down, but I really don't want to be part of it. Deciding on having the knee surgery itself was a huge step for me. Now this question comes up. I am sure the surgery and recovery will be quite stressful enough without adding any more stress factors.


Claire F Rich said...

They would rather you say no than say yes and then drop out.

My mom is participating in an Alzheimer's drug study and it's a pain to go to all the appointments and do all the tests. It's especially annoying since I'm pretty sure she's getting the placebo.

Kenyo said...

Sorry to hear your mom is in a test you think may be using the placebo. Do you know anybody else in the study who's doing extremely well?

I found out they want me in there at 5:00 A.M. next Thursday. I told the nurse I never stay up that late but she was immune to my humor, or charm for that matter.