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Completed

NCT Number: NCT02272465

Prehospital Resuscitation On Helicopter Study

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Observational study

Primary outcomes

  1. In-patient mortality.

    Time frame: Up to 30 days

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • 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

Registry information

Acronym: PROHS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2014
Registry last updated
Dec 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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