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| PROPPR trial | |
|---|---|
| Name | PROPPR |
| Acronym | PROPPR |
| Title | Pragmatic, Randomized Optimal Platelet and Plasma Ratios |
| Phase | III |
| Condition | Hemorrhagic shock, trauma |
| Interventions | Blood component ratios (1:1:1 vs 1:1:2) |
| Status | Completed |
PROPPR trial was a multicenter, randomized controlled trial comparing transfusion strategies for patients with severe traumatic hemorrhage. Conducted by a consortium of trauma centers and emergency research networks, the trial tested whether early transfusion with blood components in a 1:1:1 ratio improved clinical outcomes versus a 1:1:2 ratio. The study influenced resuscitation guidelines and transfusion practice across trauma systems in North America and internationally.
The trial emerged from debates after landmark studies such as the Iraq War experience, the Vietnam War transfusion reports, and analyses from the Iraqi Coalition and military trauma registries that suggested balanced transfusion might reduce mortality. Observational studies at institutions including Harborview Medical Center, University of Pittsburgh Medical Center, and Rocky Mountain Regional Trauma Center reported associations between high plasma and platelet use and improved survival, prompting calls for randomized evidence from groups such as the Resuscitation Outcome Consortium, the American College of Surgeons, and the National Institutes of Health. Prior trials like the CRASH-2 trial and registry analyses from the American College of Surgeons Committee on Trauma informed the protocol and ethical frameworks used in the study.
PROPPR was coordinated by a network of level I trauma centers, prominent emergency medicine investigators, and blood-banking organizations including American Red Cross and regional transfusion services. Patients with severe truncal hemorrhage meeting inclusion criteria from prehospital or Emergency Department activation underwent random allocation to receive either a 1:1:1 ratio of plasma:platelets:red blood cells or a 1:1:2 ratio using centralized randomization procedures overseen by institutional review boards such as those at University of Washington and University of Texas Southwestern Medical Center. The pragmatic protocol incorporated elements from trials like CRASH-2 trial and employed outcomes used by CONSORT guidelines. Primary endpoints included 24-hour and 30-day mortality, with secondary endpoints including hemostasis, complications, and resource utilization captured through trauma registries such as the National Trauma Data Bank.
The trial enrolled critically injured adults across multiple centers, reporting that the 1:1:1 group achieved higher rates of hemostasis and received fewer deaths due to exsanguination at 24 hours compared with the 1:1:2 group. Overall 24-hour mortality and 30-day mortality differences were analyzed with survival methods used in trials like CRASH-2 trial and compared against historical controls from the Trauma Quality Improvement Program. Secondary findings addressed transfusion volumes, reoperation rates, and rates of acute respiratory distress syndrome seen in cohorts from institutions such as Johns Hopkins Hospital and Massachusetts General Hospital.
Investigators interpreted the data to suggest that a balanced transfusion strategy approximating 1:1:1 plasma:platelet:red blood cells confers advantages in early hemorrhage control and reduces death from bleeding, aligning with prior military and civilian observational evidence from centers like Walter Reed National Military Medical Center and University of Alabama at Birmingham Hospital. The trial informed guideline revisions by organizations including the European Society for Trauma and Emergency Surgery, the American College of Surgeons Committee on Trauma, and the World Health Organization-linked emergency care initiatives. Statistical analyses referenced methods commonly applied in landmark trials such as CRASH-2 trial for interpretation of mortality endpoints.
Preplanned and post hoc subgroup analyses examined subpopulations defined by mechanism of injury (blunt vs penetrating), presence of traumatic brain injury as classified in cohorts from Madigan Army Medical Center and Ben Taub Hospital, and timing of definitive hemorrhage control consistent with studies from UCLA Medical Center. Secondary analyses evaluated complications including transfusion-related acute lung injury noted in literature from Brigham and Women's Hospital and thromboembolic events reported in registries at Cleveland Clinic. Exploratory analyses compared resource use with benchmarks from the National Blood Service and regional blood centers including the New York Blood Center.
Limitations included challenges of pragmatic enrollment under exception from informed consent policies used in emergency research overseen by entities such as the Food and Drug Administration and institutional review boards at participating sites like University of California, San Francisco. Heterogeneity across centers, variation in surgical and interventional radiology practices at institutions such as Mayo Clinic and timing differences in prehospital care involving services like London Ambulance Service limited generalizability. The trial’s power for some secondary endpoints mirrored issues seen in trials like CRASH-2 trial regarding event rates and subgroup multiplicity.
The study catalyzed updates to massive transfusion protocols at trauma centers including Johns Hopkins Hospital, University of Pittsburgh Medical Center, and military hospitals such as Brooke Army Medical Center, and influenced guidelines from the American College of Surgeons and European Society for Trauma and Emergency Surgery. It stimulated further randomized and observational work in transfusion science at institutions like Karolinska University Hospital and policy reviews by blood services including the American Red Cross and the UK Blood Transfusion Services. The trial remains frequently cited alongside the CRASH-2 trial in reviews of trauma resuscitation and continues to shape research agendas in hemorrhage control, transfusion medicine, and trauma systems improvement.
Category:Clinical trials