Prehospital Resuscitation On Helicopter Study (PROHS)
7. december 2015 opdateret af: John Holcomb, The University of Texas Health Science Center, Houston
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.
Studieoversigt
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
1049
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama
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Arizona
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Tucson, Arizona, Forenede Stater, 85721
- University of Arizona
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California
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Los Angeles, California, Forenede Stater, 90033
- University of Southern California, Los Angeles
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland School of Medicine
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Medical Center
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45221
- University of Cincinnati
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
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Texas
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Houston, Texas, Forenede Stater, 77030
- Memorial Hermann Hospital - Texas Medical Center
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Washington
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Seattle, Washington, Forenede Stater, 98104
- University of Washington- Harborview Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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.
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Observationsstudie
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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.
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Observationsstudie
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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In-patient mortality.
Tidsramme: Up to 30 days
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Up to 30 days
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Length of hospital stay
Tidsramme: Up to 30 days
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The total # of hospital days
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Up to 30 days
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Number of ICU days
Tidsramme: Up to 30 days
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Up to 30 days
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Number of Ventilator days
Tidsramme: Up to 30 days
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Up to 30 days
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Blood product usage
Tidsramme: Up to 30 days
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Number of RBCs, plasma and platelets used during resuscitation.
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Up to 30 days
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GOSE score
Tidsramme: Up to 30 days
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GOSE score to measure functional status at time of discharge
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Up to 30 days
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Number of patients with complications
Tidsramme: Up to 30 days
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Will evaluate the number of patients who experienced common complication following traumatic injury.
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Up to 30 days
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Number of patients who required hemostatic devices
Tidsramme: up to 30 days
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The use of external and internal hemostatic devices.
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up to 30 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John Holcomb, M.D., The University of Texas Health Science Center, Houston
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2015
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
9. oktober 2014
Først indsendt, der opfyldte QC-kriterier
20. oktober 2014
Først opslået (Skøn)
23. oktober 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HSC-GEN-14-0735
- U01HL077863 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .