Institutional Review Board, Hospital for Special Surgery
January 31, 2014
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.
An international collaboration, entitled the Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking ("APS ACTION") (www.apsaction.org), has created a web-based ‘Clinical Database and Repository”, which will function as:
(1) a database for better defining aPL-related clinical problems and
(2) a repository for standardizing aPL tests; and
(3) a resource for future basic science and clinical research projects.
• Age 18-75
• Persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to the entry defined as:
o aCL IgG/M/A (> 40U, medium-to-high titer, and/or greater than the 99th percentile) and/or
o aβ2GPI IgG/M/A (>40U, medium-to-high titer, and/or greater than the 99th percentile) and/or
o Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations
• Patient refusal
• Inability to comply with study and follow-up procedures
JoAnn Vega, Study Coordinator