NCT02272465

Prehospital Resuscitation On Helicopter Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,049 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Traumatic Injuries

Interventions

Type	Name	Description
OTHER	No intervention	Observational study

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-10-23
• Last updated: 2015-12-08

Locations

9 sites across 1 country: United States