Prehospital Resuscitation On Helicopter Study

Completed

• Conditions: Traumatic Injuries
• Interventions: Other: No intervention

• Registration Number: NCT02272465
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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).

Study Timeline

• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-23
• Study Start: 2015-01
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1049

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Received blood products during transport	No intervention	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.
Received crystalloid during transport	No intervention	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.

Primary Outcome Measures

Name	Time	Method
In-patient mortality.	Up to 30 days

Trial Locations

Locations (9)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Washington- Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Memorial Hermann Hospital - Texas Medical Center; 🇺🇸 Houston, Texas, United States

University of Southern California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Mayo Medical Center; 🇺🇸 Rochester, Minnesota, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States