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Prehospital Management of Hypotensive Trauma in HEMS

Study acronym: SPITFIRE
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Primary endpoint(s) modified Show 8 more changesShow less
    • Primary completion date changed from estimate of May 1, 2025 to Mar 31, 2026
    • Trial status changed: Unknown → Completed
    • Final enrollment: 1268 participants (planned 500)
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Site details revised at 16 of 16 sites
    • Publications: details revised at 6 of 6 entries
    • Eligibility criteria expanded, about 5 words
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Recruiting to Unknownv4
  4. Enrollment target: 400 to 500
    • Interventions: Blood transfusions (Biological), Drugs administration (Drug), Prehospital management (Other), Resuscitative endovascular balloon occlusion… to Blood transfusions (Biological), Drugs administration (Drug), Prehospital eFAST (Device), Prehospital management (Other), Resuscitative…
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Secondary endpoints: 5 to 4
    • Site details revised at 16 of 16 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04760977
Lead Sponsor Azienda Usl di Bologna
Conditions
(from sponsor)		 Hypotension and Shock, Wounds and Injuries, Emergencies, Critical Care
Related terms Emergencies, Hypotension, Shock, Wounds and Injuries
Enrollment 1,268 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov