Clinical Trial

Prehospital Management of Hypotensive Trauma in HEMS

Study acronym: SPITFIRE
Recruiting
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Record status
This record was last updated August 13, 2024 (before its estimated May 1, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-02-17; most recent amendment 2024-08-10.
Status change: Not Yet Recruiting → Recruiting 2021-06-25
Trial Details
NCT Number NCT04760977
Lead Sponsor Azienda Usl di Bologna
Conditions Hypotension and Shock, Wounds and Injuries, Emergencies, Critical Care
Enrollment 500 participants
Start Date 2021-05-01
Primary Completion 2025-05-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-13