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NCT Number: NCT04760977

Prehospital Management of Hypotensive Trauma in HEMS

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Alessandria, Alessandria, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drugs administration

Drug

Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents

Resuscitative endovascular balloon occlusion of the aorta

Device

Resuscitative technique for exsanguinating traumas

Other names: REBOA

Blood transfusions

Biological

Transfuion of transported blood products for exsanguinating traumas

Prehospital management

Other

Stay and play strategy vs scoop and run

Prehospital eFAST

Device

Prehospital thorax/abdomen extended focused assessment sonography for trauma

Primary outcomes

  1. 30 days mortality

    Time frame: 30 days

Secondary outcomes

  1. survival from prehospital to hospital admmission

    Time frame: 1 day

  2. Hospital length of stay

    Time frame: 6 months

  3. Blood products transfused during the first 24 hours after hospital admission

    Time frame: 24 hours

  4. Transport time

    Time frame: 24 hours

    time from dispatch to hospital admission (if any)

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Gamberini, MD

CONTACT

[email protected]

Marco Tartaglione, MD

CONTACT

[email protected]

+390516368215

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Acronym: SPITFIRE

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 18, 2021
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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