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Prehospital Resuscitation On Helicopter Study (PROHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272465
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : December 8, 2015
Sponsor:
Collaborators:
University of Cincinnati
Mayo Clinic
Oregon Health and Science University
University of Washington
University of Maryland, College Park
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

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.

Condition or disease Intervention/treatment
Traumatic Injuries Other: No intervention

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).

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Study Type : Observational
Actual Enrollment : 1049 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prehospital Resuscitation On Helicopter Study
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Group/Cohort Intervention/treatment
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.
Other: No intervention
Observational study

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.
Other: No intervention
Observational study




Primary Outcome Measures :
  1. In-patient mortality. [ Time Frame: Up to 30 days ]

Other Outcome Measures:
  1. Length of hospital stay [ Time Frame: Up to 30 days ]
    The total # of hospital days

  2. Number of ICU days [ Time Frame: Up to 30 days ]
  3. Number of Ventilator days [ Time Frame: Up to 30 days ]
  4. Blood product usage [ Time Frame: Up to 30 days ]
    Number of RBCs, plasma and platelets used during resuscitation.

  5. GOSE score [ Time Frame: Up to 30 days ]
    GOSE score to measure functional status at time of discharge

  6. Number of patients with complications [ Time Frame: Up to 30 days ]
    Will evaluate the number of patients who experienced common complication following traumatic injury.

  7. Number of patients who required hemostatic devices [ Time Frame: up to 30 days ]
    The use of external and internal hemostatic devices.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272465


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85721
United States, California
University of Southern California, Los Angeles
Los Angeles, California, United States, 90033
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Minnesota
Mayo Medical Center
Rochester, Minnesota, United States, 55905
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45221
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington- Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of Cincinnati
Mayo Clinic
Oregon Health and Science University
University of Washington
University of Maryland, College Park
University of Alabama at Birmingham
University of Arizona
University of Southern California
National Heart, Lung, and Blood Institute (NHLBI)
Resuscitation Outcomes Consortium
Investigators
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Principal Investigator: John Holcomb, M.D. The University of Texas Health Science Center, Houston

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Responsible Party: John Holcomb, M.D., Chief Division of Acute Care Surgery, Director Center for Translational Injury Research, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02272465    
Other Study ID Numbers: HSC-GEN-14-0735
U01HL077863 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by John Holcomb, The University of Texas Health Science Center, Houston:
pre-hospital resuscitation, helicopter, trauma
Additional relevant MeSH terms:
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Wounds and Injuries