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consent in 12 sites across the country, enrollment of prisoners, and follow-up for those whom consent has been withdrawn will be discussed.