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Prehospital Management of Hypotensive Trauma in HEMS

Prehospital Management of Hypotensive Trauma in HEMS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04760977
Acronym
SPITFIRE
Enrollment
500
Registered
2021-02-18
Start date
2021-05-01
Completion date
2026-05-01
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Emergencies, Hypotension and Shock, Wounds and Injuries

Keywords

Transportation of Patients, Wounds and Injuries, Emergencies, Critical Care

Brief summary

Up to today, inadequate evidences and knowledge exist about the best prehospital management of hypotensive trauma patients and its clinical consequence on the in-hospital recovery and mortality. Also new emerging therapies such as prehospital blood transfusion and REBOA (resuscitative endovascular balloon occlusion of the aorta) are lacking strong evidences in, eventually, reducing hospital mortality and improving outcomes. Moreover, prehospital emergency medicine is throughout Italy an heterogeneous system that has no unique standard operating procedures and, even among HEMS (helicopter emergency medical service), management and therapies on complex trauma patients may vary upon local policies. With this study we aim to enroll hypotensive trauma patients and study factors of prehospital rescue that can be associated with in-hospital mortality and recovery, eventually even with hospital outcome. For each patients data as demographic, kind of trauma (mechanism, injury scores), therapies and maneuvers will be recorded and then analyzed in comparison with in-hospital data such as need for transfusion, ABG parameters, length of stay (in-ward and ICU), need of therapies like invasive ventilation and renal replacement therapy, recovery and outcome

Interventions

Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents

DEVICEResuscitative endovascular balloon occlusion of the aorta

Resuscitative technique for exsanguinating traumas

BIOLOGICALBlood transfusions

Transfuion of transported blood products for exsanguinating traumas

OTHERPrehospital management

Stay and play strategy vs scoop and run

DEVICEPrehospital eFAST

Prehospital thorax/abdomen extended focused assessment sonography for trauma

Sponsors

Azienda Usl di Bologna
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years * Witnessed traumatic event managed by HEMS * Shock at first evaluation (Systolic blood pressure \< 90 mmHg) * Suspect or obvious ongoing haemorrage

Exclusion criteria

* Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew

Design outcomes

Primary

MeasureTime frame
30 days mortality30 days

Secondary

MeasureTime frameDescription
survival from prehospital to hospital admmission1 day
Hospital length of stay6 months
Blood products transfused during the first 24 hours after hospital admission24 hours
Transport time24 hourstime from dispatch to hospital admission (if any)

Countries

Italy

Contacts

Primary ContactMarco Tartaglione, MD
marco.tartaglione@ausl.bologna.it+390516368215
Backup ContactLorenzo Gamberini, MD
lorenzo.gamberini@ausl.bologna.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026