Prehospital Resuscitation On Helicopter Study (PROHS)
7. desember 2015 oppdatert av: 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.
Studieoversikt
Detaljert 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).
Studietype
Observasjonsmessig
Registrering (Faktiske)
1049
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35233
- University of Alabama
-
-
Arizona
-
Tucson, Arizona, Forente stater, 85721
- University of Arizona
-
-
California
-
Los Angeles, California, Forente stater, 90033
- University of Southern California, Los Angeles
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21201
- University of Maryland School of Medicine
-
-
Minnesota
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Medical Center
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45221
- University of Cincinnati
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Memorial Hermann Hospital - Texas Medical Center
-
-
Washington
-
Seattle, Washington, Forente stater, 98104
- University of Washington- Harborview Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
15 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Observasjonsstudie
|
|
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.
|
Observasjonsstudie
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
In-patient mortality.
Tidsramme: Up to 30 days
|
Up to 30 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of hospital stay
Tidsramme: Up to 30 days
|
The total # of hospital days
|
Up to 30 days
|
|
Number of ICU days
Tidsramme: Up to 30 days
|
Up to 30 days
|
|
|
Number of Ventilator days
Tidsramme: Up to 30 days
|
Up to 30 days
|
|
|
Blood product usage
Tidsramme: Up to 30 days
|
Number of RBCs, plasma and platelets used during resuscitation.
|
Up to 30 days
|
|
GOSE score
Tidsramme: Up to 30 days
|
GOSE score to measure functional status at time of discharge
|
Up to 30 days
|
|
Number of patients with complications
Tidsramme: Up to 30 days
|
Will evaluate the number of patients who experienced common complication following traumatic injury.
|
Up to 30 days
|
|
Number of patients who required hemostatic devices
Tidsramme: up to 30 days
|
The use of external and internal hemostatic devices.
|
up to 30 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: John Holcomb, M.D., The University of Texas Health Science Center, Houston
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2015
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
9. oktober 2014
Først innsendt som oppfylte QC-kriteriene
20. oktober 2014
Først lagt ut (Anslag)
23. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSC-GEN-14-0735
- U01HL077863 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .