Traumatic Injuries Clinical Trial
— PROHSOfficial title:
Prehospital Resuscitation On Helicopter Study
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.
Status | Completed |
Enrollment | 1049 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland School of Medicine | Baltimore | Maryland |
United States | University of Alabama | Birmingham | Alabama |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Memorial Hermann Hospital - Texas Medical Center | Houston | Texas |
United States | University of Southern California, Los Angeles | Los Angeles | California |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Mayo Medical Center | Rochester | Minnesota |
United States | University of Washington- Harborview Medical Center | Seattle | Washington |
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University, Resuscitation Outcomes Consortium, University of Alabama at Birmingham, University of Arizona, University of Cincinnati, University of Maryland, University of Southern California, University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Length of hospital stay | The total # of hospital days | Up to 30 days | No |
Other | Number of ICU days | Up to 30 days | No | |
Other | Number of Ventilator days | Up to 30 days | No | |
Other | Blood product usage | Number of RBCs, plasma and platelets used during resuscitation. | Up to 30 days | No |
Other | GOSE score | GOSE score to measure functional status at time of discharge | Up to 30 days | No |
Other | Number of patients with complications | Will evaluate the number of patients who experienced common complication following traumatic injury. | Up to 30 days | No |
Other | Number of patients who required hemostatic devices | The use of external and internal hemostatic devices. | up to 30 days | No |
Primary | In-patient mortality. | Up to 30 days | No |
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