Institutional Review Board, Hospital for Special Surgery
July 06, 2005
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
The purpose of the research is to investigate if combinations of the genetic prothrombotic factors such as, AT III, PAI-1 4G/4G, and prothrombin G20210A demonstrate an association with blood clotting therefore increasing the risk of developing hypercoagulation-based complications such as Deep Venous Thrombosis and Pulmonary Emboli. The researchers want to learn if a blood test could help to determine which patients are at a higher risk of developing these clots. They want to determine if people with a positive test for a blood clot also have certain molecular markers (chemicals) in their blood compared to people who do not have a clot. The researchers expect to enroll 500 patients in this research study which will involve one visit, lasting about fifteen minutes.
Geoffrey Westrich, MD
Hospital for Special Surgery
535 East 70th Street, Rm. 324
New York, NY 10021