Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: design, rationale and implementation

Area of Science:

• Trauma Resuscitation
• Hemorrhagic Shock Management
• Clinical Trial Design

Background:

• Massive truncal hemorrhage accounts for 40% of in-hospital deaths in trauma patients.
• Rapid hemorrhage control and advanced resuscitation are critical for survival.
• The PROPPR trial investigated optimal ratios of blood products for massive transfusion protocols.

Purpose of the Study:

• To determine if different ratios of plasma, platelets, and red blood cells impact mortality in severely injured patients.
• To assess the feasibility of conducting a large-scale randomized trial in trauma patients under Exception from Informed Consent (EFIC).

Main Methods:

• A Phase III randomized trial involving 12 North American trauma centers.
• Patients with highest trauma activation and predicted massive transfusion were randomized to 1:1:1 or 1:1:2 ratios of plasma:platelets:red blood cells.
• Data and samples collected under EFIC regulations, with co-primary mortality endpoints at 24 hours and 30 days.

Main Results:

• 680 patients were randomized between August 2012 and December 2013.
• Median time from admission to randomization was 26 minutes.
• The trial demonstrated high enrollment rates and low protocol deviation rates.

Conclusions:

• The PROPPR trial is the largest randomized study of severely bleeding patients to date.
• Successfully enrolling and randomizing trauma patients under EFIC is feasible.
• The study's design and procedures offer a model for future trauma resuscitation research.