Prehospital Resuscitation On Helicopter Study

NCT02272465 | Completed

• 2 other identifiers: HSC-GEN-14-0735U01HL077863
• Study Type: observational
• Target: 1,049
• Locations: 1 country
• Sites: 9

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.

Conditions

Traumatic Injuries

Keywords

pre-hospital resuscitation, helicopter, trauma

Outcome Measures

Primary Outcomes (1)

• In-patient mortality.

  Up to 30 days

Other Outcomes (7)

• Length of hospital stay

  Up to 30 days

• Number of ICU days

  Up to 30 days

• Number of Ventilator days

  Up to 30 days

Study Arms (2)

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.

Other: No intervention

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.

Other: No intervention

Interventions

No intervention OTHER

Observational study

Received blood products during transport; Received crystalloid during transport

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is trauma patients who are transported to one of the participating Level I trauma centers via air ambulance, directly from the scene, and meet the eligibility criteria.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• University of Cincinnati: collaborator
• Mayo Clinic: collaborator
• Oregon Health and Science University: collaborator
• University of Washington: collaborator
• University of Maryland: collaborator
• University of Alabama at Birmingham: collaborator
• University of Arizona: collaborator
• University of Southern California: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Resuscitation Outcomes Consortium: collaborator

Study Sites (9)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Arizona

Tucson, Arizona, 85721, United States

Location

University of Southern California, Los Angeles

Los Angeles, California, 90033, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Mayo Medical Center

Rochester, Minnesota, 55905, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

University of Washington- Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• John Holcomb, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief Division of Acute Care Surgery, Director Center for Translational Injury Research

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 23, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

US (9)