Clinical trial NCT02272465: Prehospital Resuscitation On Helicopter Study
Official title: Prehospital Resuscitation On Helicopter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Injuries
Keywords: pre-hospital resuscitation, helicopter, trauma
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
name: Mayo Clinic
name: Oregon Health and Science University
name: University of Washington
name: University of Maryland
name: University of Alabama at Birmingham
name: University of Arizona
name: University of Southern California
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Resuscitation Outcomes Consortium
First posted: 2014-10-23
Enrollment: 1049
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: In-patient mortality.
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
measure: Length of hospital stay
timeFrame: Up to 30 days
measure: Number of ICU days
timeFrame: Up to 30 days
measure: Number of Ventilator days
timeFrame: Up to 30 days
measure: Blood product usage
timeFrame: Up to 30 days
measure: GOSE score
timeFrame: Up to 30 days
measure: Number of patients with complications
timeFrame: Up to 30 days
measure: Number of patients who required hemostatic devices
timeFrame: up to 30 days
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California, Los Angeles
state: California
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Rochester
country: United States
facility: Mayo Medical Center
state: Minnesota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Houston
country: United States
facility: Memorial Hermann Hospital - Texas Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington- Harborview Medical Center
state: Washington
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John Holcomb, M.D.
role: PRINCIPAL_INVESTIGATOR
References: