Prehospital Resuscitation on Helicopter Study (PROHS)
Start Date: April 3, 2015-2017
Enrolling: This clinical trial will screen 20,000 patients and target enrollment is 1000 patients. Tucson enrollment is likely to be approximately 120 patients
Principal Investigator: Terence O’Keeffe, MD, MSPH, Associate Professor of Surgery
Interests: Massive transfusion practices and injury prevention
Sponsor: The Department of Defense
Research Coordinator: Laurel Rokowski, RN Laurel@surgery.arizona.edu
The Prehospital Resuscitation on Helicopter Study (PROHS) is a pragmatic, multicenter, prospective observational study of air ambulance-based prehospital resuscitation regimens currently utilized at 10 Level 1 trauma centers in the United States. Patients will be enrolled at participating trauma centers that currently have blood products available on air ambulances and other sites that do not. This study will not change the current prehospital standard of care for resuscitation. Banner University Medical Center will be control group 2 as we currently do not give blood to patients on the way to the hospital.
The primary outcome will be 30 day in-hospital mortality and the primary unit of analysis will be the patient. Other outcomes of interest will include 24-hour in-hospital mortality, time to control of bleeding, hospital length-of-stay, number of ventilator-free and ICU-free days, incidence of major surgical procedures, complications (transfusion-related acute lung injury [TRALI], acute kidney injury [AKI], multiple organ failure [MOF], acute respiratory distress syndrome [ARDS], sepsis, intra-abdominal complications, thromboembolic complications, compartment syndromes), lifesaving interventions, the amount and type of blood products and concentrates transfused (including prehospital), wastage of prehospital blood products and concentrates, use of external and internal hemostatic devices, and functional status at discharge/discharge destination.
Hypothesis and Specific Aims:
The objective of this study is to compare the effectiveness of two different existing prehospital resuscitation approaches in severely injured trauma patients transported by air ambulance in a pragmatic, multicenter, prospective observational study. Hypothesis: Patients with severe traumatic injuries who are evacuated to a Level I trauma center on air ambulances and who receive plasma and/or red blood cells (RBCs) (Group 1) will have lower 30 day in-hospital mortality compared to patients evacuated on an air ambulance and who don’t receive any prehospital blood products (Group 2).
Aim 1.1 Compare routinely collected prehospital vital signs and demographics, prior to in-transit resuscitation to assess whether groups were similar at baseline.
Aim 1.2 Compare 24 hour and 30 day in-hospital mortality and time to death between groups, adjusting for potential confounders including center.
Aim 1.3 Assess additional outcomes of interest, including amount of products infused and subsequent need for early hospital transfusion.