Prehospital Resuscitation On Helicopter Study (PROHS)

The Prehospital Resuscitation On Helicopter Study (PROHS) is a pragmatic, multicenter, prospective observational study of air ambulance-based prehospital resuscitation regimens currently utilized at the participating sites. Patients will be enrolled at participating sites 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. 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 hemostasis, 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.

Study phase: I

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Patients meeting the following inclusion criteria will be enrolled in this study.
1) Patients with traumatic injuries received directly from the scene via air ambulance service (did not receive a lifesaving intervention at an outside hospital or healthcare facility)
2) Estimated age of 15 or older or greater than/equal to a weight of 50 kg, if age unknown
Subset Inclusion Criteria (Highest risk population):
Patients meeting the following inclusion criteria will be followed for direct observation data collection after hospital admission.
1) Meet at least one of the following during prehospital care: HR >120 bpm, SBP ?90 mmHg, penetrating truncal injury, tourniquet application, pelvic binder application or intubation.
2) Received blood products during transport (for those facilities with blood product availability)

6.4. Exclusion Criteria:
1) Prisoners, defined as those received directly from a correctional facility. Justification: Prisoners are excluded because of their vulnerable population status.

Primary disease category: Heart/Cardiovascular

Sponsor: Department of Defense

Protocol number: 05-20-2014

Projected enrollment dates: April 2015 to June 2018

Official study title: Prehospital Resuscitation On Helicopter Study (PROHS)

ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT02272465