Prehospital Resuscitation On Helicopter Study (PROHS)

• ClinicalTrials.gov Identifier: NCT02272465
• Recruitment Status: Completed
• First Posted: October 23, 2014
• Last Update Posted: December 8, 2015
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: 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
• Information provided by (Responsible Party): John Holcomb, The University of Texas Health Science Center, Houston

Tracking Information

• First Submitted Date: October 9, 2014
• First Posted Date: October 23, 2014
• Last Update Posted Date: December 8, 2015
• Study Start Date: January 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2014): In-patient mortality. [ Time Frame: Up to 30 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: October 20, 2014)

• Length of hospital stay [ Time Frame: Up to 30 days ]
  The total # of hospital days
• Number of ICU days [ Time Frame: Up to 30 days ]
• Number of Ventilator days [ Time Frame: Up to 30 days ]
• Blood product usage [ Time Frame: Up to 30 days ]
  Number of RBCs, plasma and platelets used during resuscitation.
• GOSE score [ Time Frame: Up to 30 days ]
  GOSE score to measure functional status at time of discharge
• Number of patients with complications [ Time Frame: Up to 30 days ]
  Will evaluate the number of patients who experienced common complication following traumatic injury.
• Number of patients who required hemostatic devices [ Time Frame: up to 30 days ]
  The use of external and internal hemostatic devices.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Prehospital Resuscitation On Helicopter Study
• Official Title: Prehospital Resuscitation On Helicopter Study
• 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).
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Traumatic Injuries

Intervention

Other: No intervention

Observational study

Study Groups/Cohorts

• 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.
  Intervention: Other: No intervention
• 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.
  Intervention: Other: No intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2015): 1049
• Original Estimated Enrollment (submitted: October 20, 2014): 1000
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02272465
• Other Study ID Numbers: HSC-GEN-14-0735; U01HL077863 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: John Holcomb, The University of Texas Health Science Center, Houston
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current

Collaborators

• 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

Investigators

• Principal Investigator: John Holcomb, M.D.; The University of Texas Health Science Center, Houston

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: December 2015