Prehospital Resuscitation On Helicopter Study

Traumatic Injuries Clinical Trial

— PROHS  

Official title:

Prehospital Resuscitation On Helicopter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272465
• Other study ID #: HSC-GEN-14-0735
• Secondary ID: U01HL077863
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: December 7, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Traumatic Injuries
• Wounds and Injuries

Intervention

Other:
• No intervention
Observational study

Locations

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

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

Outcome

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