Traumatic Injuries
Conditions
Keywords
pre-hospital resuscitation, helicopter, trauma
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.
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).
Interventions
OTHERNo intervention
Observational study
Sponsors
University of Cincinnati
Mayo Clinic
Oregon Health and Science University
University of Washington
University of Maryland
University of Alabama at Birmingham
University of Arizona
University of Southern California
National Heart, Lung, and Blood Institute (NHLBI)
Resuscitation Outcomes Consortium
The University of Texas Health Science Center, Houston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-patient mortality. | Up to 30 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of ICU days | Up to 30 days | — |
| Number of Ventilator days | Up to 30 days | — |
| Blood product usage | Up to 30 days | Number of RBCs, plasma and platelets used during resuscitation. |
| Length of hospital stay | Up to 30 days | The total # of hospital days |
| Number of patients with complications | Up to 30 days | Will evaluate the number of patients who experienced common complication following traumatic injury. |
| Number of patients who required hemostatic devices | up to 30 days | The use of external and internal hemostatic devices. |
| GOSE score | Up to 30 days | GOSE score to measure functional status at time of discharge |
Countries
United States
Outcome results
None listed