Phase 3
N=680
Pragmatic, Randomized Optimal Platelet and Plasma Ratios
Trauma
Bottom Line
View on ClinicalTrials.gov: NCT01545232 ↗Enrolled (actual)
680
Serious AEs
0.9%
Results posted
Jun 2015
Primary outcome: Primary: 24-hour Mortality — 43; 58 participants — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 1:1:1 Blood Transfusion Ratio (Biological); 1:1:2 Blood Transfusion Ratio (Biological)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour Mortality |
43; 58 | 0.12 |
| PRIMARY 30-day Mortality |
75; 89 | 0.26 |
| PRIMARY Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) |
45; 42 | — |
| SECONDARY Hospital Free Days |
1; 0 | 0.83 |
| SECONDARY Time to Hemostasis |
105; 100 | 0.44 |
| SECONDARY Amount of Randomized Blood Products Given to Hemostasis |
16; 15 | — |
| SECONDARY Functional Status at Time of Hospital Discharge |
4; 4.5 | 0.11 |
| SECONDARY Incidence of Primary Surgical Procedure |
290; 284 | — |
| SECONDARY Incidence of Transfusion Related Serious Adverse Events |
1; 0 | — |
| SECONDARY Initial Hospital Discharge Status |
118; 105; 82; 77; 59; 71 | 0.37 |
| SECONDARY Ventilator Free Days |
8; 7 | 0.14 |
| SECONDARY ICU Free Days |
5; 4 | 0.10 |
| SECONDARY Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission |
1; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01545232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.