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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.
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).
Age
15 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
January 1, 2015
Primary Completion Date
December 1, 2015
Completion Date
December 1, 2015
Last Updated
December 8, 2015
1,049
ACTUAL participants
No intervention
OTHER
Lead Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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