Prehospital Resuscitation On Helicopter Study (PROHS)

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Injuries
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 1049

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California, Los Angeles
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital - Texas Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington- Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: No intervention; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-patient mortality.	Up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	The total # of hospital days	Up to 30 days
Number of ICU days		Up to 30 days
Number of Ventilator days		Up to 30 days
Blood product usage	Number of RBCs, plasma and platelets used during resuscitation.	Up to 30 days
GOSE score	GOSE score to measure functional status at time of discharge	Up to 30 days
Number of patients with complications	Will evaluate the number of patients who experienced common complication following traumatic injury.	Up to 30 days
Number of patients who required hemostatic devices	The use of external and internal hemostatic devices.	up to 30 days

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Mayo Clinic; National Heart, Lung, and Blood Institute (NHLBI); University of Maryland; University of Alabama at Birmingham; University of Southern California; Oregon Health and Science University; University of Washington; University of Cincinnati; University of Arizona; Resuscitation Outcomes Consortium
• Investigators: Principal Investigator: John Holcomb, M.D., The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: pre-hospital resuscitation, helicopter, trauma
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: HSC-GEN-14-0735; U01HL077863 (U.S. NIH Grant/Contract)