Traumatic InjuriesPROHSNCT02272465
Prehospital Resuscitation On Helicopter Study
An observational study of Traumatic Injuries, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Traumatic Injuries
- How many people
- 1,049 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Prisoners (defined as those received directly from a correctional facility.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35233
University of Cincinnati
Cincinnati, Ohio, 45221
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
University of Southern California, Los Angeles
Los Angeles, California, 90033
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Medical Center
Rochester, Minnesota, 55905
University of Washington- Harborview Medical Center
Seattle, Washington, 98104
University of Arizona
Tucson, Arizona, 85721
About this 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.
Read the 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).
- Conditions
- Traumatic Injuries
- Being tested
- No intervention
- Keywords
- pre-hospital resuscitation, helicopter, trauma
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-patient mortality.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,049 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, John Holcomb, The University of Texas Health Science Center, Houston
- Investigators
- John Holcomb, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272465
- Sponsor's protocol ID
- HSC-GEN-14-0735
- Other IDs
- U01HL077863
- Acronym
- PROHS
- Status last verified
- Dec 2015
- First submitted
- 9 Oct 2014
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Resuscitation On Helicopter Study
- ClinicalTrials.gov ID
- NCT02272465
- Acronym / sponsor ID
- PROHS / HSC-GEN-14-0735
- Conditions
- Traumatic Injuries
- Keywords
- pre-hospital resuscitation, helicopter, trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,049 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- 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
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received blood products during transport | – | Other: No interventionThere 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. |
| Received crystalloid during transport | – | Other: No interventionThere 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Prisoners (defined as those received directly from a correctional facility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study | Other | Received blood products during transport, Received crystalloid during transport |
Primary outcome
In-patient mortality.
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Holcomb, M.D. principal investigator
The University of Texas Health Science Center, Houston
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Injuries, run by The University of Texas Health Science Center, Houston at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-patient mortality. (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.