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Clinical Trials/NCT04760977
NCT04760977
Recruiting
Not Applicable

Prehospital Management of Hypotensive Trauma in HEMS

Azienda Usl di Bologna15 sites in 1 country500 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Drugs administration
Conditions
Hypotension and Shock
Sponsor
Azienda Usl di Bologna
Enrollment
500
Locations
15
Primary Endpoint
30 days mortality
Status
Recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
May 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

Intervention: Drugs administration

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

Intervention: Resuscitative endovascular balloon occlusion of the aorta

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

Intervention: Blood transfusions

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

Intervention: Prehospital management

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

Intervention: Prehospital eFAST

Outcomes

Primary Outcomes

30 days mortality

Time Frame: 30 days

Secondary Outcomes

  • survival from prehospital to hospital admmission(1 day)
  • Hospital length of stay(6 months)
  • Transport time(24 hours)
  • Blood products transfused during the first 24 hours after hospital admission(24 hours)

Study Sites (15)

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