Prehospital Resuscitation On Helicopter Study (PROHS)

The University of Texas System (UT)

Status: Completed

Conditions: Traumatic Injuries

Treatments: Other: No intervention

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT02272465

HSC-GEN-14-0735

U01HL077863 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 in-hospital mortality and the primary unit of analysis will be the patient. Other outcomes of interest will include 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.

Full description

All patients arriving to the participating center's trauma emergency department via helicopter directly from the scene will be screened and initial data collected. Of that group, all patients who meet the "highest risk" category (based on vital signs, type of injury, use of tourniquet, and/or intubation) or received blood during transport will be followed through "direct observation" through the initial resuscitation period and then indirectly through medical chart review until hospital discharge or 30 days after admission (whichever occurs first).

Enrollment: 1,049 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Criteria for "at risk" population

• 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)
• Estimated age of 15 or older or greater than/equal to a weight of 50 kg, if age unknown Criteria for "highest risk" population
• 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.
• Received blood products during transport (for those facilities with blood product availability)

Exclusion criteria

• Prisoners (defined as those received directly from a correctional facility.

Trial design

1,049 participants in 2 patient groups

Received blood products during transport

Description:

There is no intervention as this is an observational study. The first group will be the patients that received blood products during the helicopter transport from the scene of the injury per standard of care guidelines at the participating institutions.

Treatment:

Other: No intervention

Received crystalloid during transport

Description:

There is no study intervention. The second group will be the patients that did not receive blood products during the helicopter transport because blood products are not available or part of the standard of care during flight.

Treatment:

Other: No intervention