Institutional Review Board, Hospital for Special Surgery
December 13, 2012
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.
Warfarin therapy after hip and knee replacement: Pharmacogenetic versus clinical warfarin dosing, and low versus high intensity warfarin (INR goal 1.8 versus 2.5). 1600 patients will be enrolled at four sites, 500 of them at HSS. Patients are treated with warfarin for 35 days, and followed for 90 days after surgery.
Scheduled for elective hip or knee arthroplasty. Age = 65 years; Medicare insurance; Anticipate taking warfarin therapy for at least 1 month for prophylaxis; Able to give written, informed consent; Reliable telephone access; Able to return at 4-6 weeks for a Doppler ultrasound.
Currently taking warfarin; Genotype known; Therapeutic warfarin dose known; Institutionalized; Unlikely to be compliant; Allergy to warfarin; Bleeding disorder; History of major bleeding ; History of thromboembolism ; History of thrombophilia; First degree relative with VTE before the age of 50; Baseline INR > 1.35; Plan to receive LMWH, heparin (except flushes) or fondaparinux (Aspirin, persantine, ticlopidine or clopidogrel (Plavix) allowed).
Anne R. Bass, MD