Pragmatic, Randomized Optimal Platelet and Plasma Ratios
Condition: Trauma
MeSH terms: Wounds and Injuries
Intervention: 1:1:1 Blood Transfusion Ratio; 1:1:2 Blood Transfusion Ratio
Intervention description: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.; Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 680.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Massive Transfusion; Trauma; Coagulopathy; Trauma Induced Coagulopathy; Plasma; Platelets; Red Blood Cells; Mortality; Wounds and Injuries; Shock, Hemorrhagic; Shock; Pathologic Processes; Hemorrhage; Hemostatics; Coagulation; Transfusion-related acute lung injury (TRALI); Inflammation

Summary:

      Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial
      designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted
      to receive massive transfusion ([MT] (defined as receiving 10 units or more red blood cells
      (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which
      clinicians make decisions about transfusion protocols for massively bleeding patients.

      PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National
      Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and
      the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at
      Level I Adult Trauma Centers in North America.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who require the highest trauma team activation at each participating center,

          -  Estimated age of 15 years or older or greater than/equal to weight of 50 kg if age
             unknown,

          -  Received directly from the injury scene,

          -  Initiated transfusion of at least one unit of blood component within the first hour of
             arrival or during prehospital transport, and

          -  Predicted to receive a MT by exceeding the threshold score of either the Assessment of
             Blood Consumption (ABC) score or the attending trauma physician's judgment criteria

        Exclusion Criteria:

          -  Received care (as defined as receiving a life saving intervention) from an outside
             hospital or healthcare facility (Procedures and care given at an outside health
             facility cannot be documented or controlled resulting in a high variability of
             standards of care and clinical outcomes.)

          -  Moribund patient with devastating injuries and expected to die within one hour of
             Emergency Department (ED) admission

          -  Prisoners, defined as those who have been directly admitted from a correctional
             facility

          -  Patients requiring an emergency thoracotomy

          -  Children under the age of 15 years or under 50 kg body weight if age unknown

          -  Known pregnancy in the ED

          -  Greater than 20% total body surface area (TBSA) burns

          -  Suspected inhalation injury

          -  Received greater than five consecutive minutes of cardiopulmonary resuscitation (CPR
             with chest compressions) in the pre-arrival or ED setting

          -  Known Do Not Resuscitate (DNR) prior to randomization

          -  Enrolled in a concurrent, ongoing interventional, randomized clinical trial

          -  Patients who have activated the "opt-out" process or patients/legally authorized
             representatives that refuse blood products on arrival to ED.