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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL077863 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Cincinnati | OTHER |
| Mayo Clinic | OTHER |
| Oregon Health and Science University | OTHER |
| University of Washington |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Observational study |
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| Measure | Description | Time Frame |
|---|---|---|
| In-patient mortality. | Up to 30 days |
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| 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 |
Inclusion Criteria:
Criteria for "at risk" population
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| John Holcomb, M.D. | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of Arizona |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| OTHER |
| University of Maryland | OTHER |
| University of Alabama at Birmingham | OTHER |
| University of Arizona | OTHER |
| University of Southern California | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Resuscitation Outcomes Consortium | NETWORK |
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| 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 |
| Tucson |
| Arizona |
| 85721 |
| United States |
| University of Southern California, Los Angeles | Los Angeles | California | 90033 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Mayo Medical Center | Rochester | Minnesota | 55905 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Memorial Hermann Hospital - Texas Medical Center | Houston | Texas | 77030 | United States |
| University of Washington- Harborview Medical Center | Seattle | Washington | 98104 | United States |