Prehospital Resuscitation On Helicopter Study

NCT ID: NCT02272465

Last Updated: 2015-12-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1049 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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).

Conditions

Traumatic Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Received blood products during transport

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.

No intervention

Intervention Type: OTHER

Observational study

Received crystalloid during transport

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.

No intervention

Intervention Type: OTHER

Observational study

Interventions

No intervention

Observational study

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Resuscitation Outcomes Consortium

NETWORK

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

John Holcomb

M.D., Chief Division of Acute Care Surgery, Director Center for Translational Injury Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Holcomb, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Alabama

Birmingham, Alabama, United States

University of Arizona

Tucson, Arizona, United States

University of Southern California, Los Angeles

Los Angeles, California, United States

University of Maryland School of Medicine

Baltimore, Maryland, 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

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, United States

University of Washington- Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

U01HL077863

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-GEN-14-0735

Identifier Type: -

Identifier Source: org_study_id