Application of EFIC in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial
*Barbara C. Tilley, University of Texas School of Public Health Keywords: Transfusion studies Clinical trials PROPPR is a Phase III multi-site, randomized trial in subjects predicted to receive massive transfusion of blood products after traumatic injury, comparing the efficacy and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with the 1:1:2 ratio. The co-primary outcomes are 24-hour and 30-day mortality. Subjects are entered into the trial under the FDA guidelines pertaining to Exception From Informed Consent (EFIC). Issues in the application of the EFIC process to community consent in 12 sites across the country, enrollment of prisoners, and follow-up for those whom consent has been withdrawn will be discussed.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC