Prehospital Management of Hypotensive Trauma in HEMS

Recruiting

• Conditions: Wounds and Injuries; Critical Care; Emergencies; Hypotension and Shock
• Interventions: Drug: Drugs administration; Device: Resuscitative endovascular balloon occlusion of the aorta; Biological: Blood transfusions; Other: Prehospital management; Device: Prehospital eFAST

• Registration Number: NCT04760977
• Lead Sponsor: Azienda Usl di Bologna

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Study Start: 2021-05-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-10
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trauma patients in shock	Prehospital management	The study focuses on hypotensive trauma patients assisted by HEMS teams
Trauma patients in shock	Blood transfusions	The study focuses on hypotensive trauma patients assisted by HEMS teams
Trauma patients in shock	Drugs administration	The study focuses on hypotensive trauma patients assisted by HEMS teams
Trauma patients in shock	Resuscitative endovascular balloon occlusion of the aorta	The study focuses on hypotensive trauma patients assisted by HEMS teams
Trauma patients in shock	Prehospital eFAST	The study focuses on hypotensive trauma patients assisted by HEMS teams

Primary Outcome Measures

Name	Time	Method
30 days mortality	30 days

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Ospedale di Alessandria; 🇮🇹 Alessandria, Italy

Ospedale di Bolzano; 🇮🇹 Bologna, Italy

Pavullo HEMS base; 🇮🇹 Pavullo Nel Frignano, Italy

Base HEMS Trento; 🇮🇹 Trento, Italy

Base HEMS Aosta; 🇮🇹 Aosta, Italy

Ospedale di Padova; 🇮🇹 Padova, Italy

Ospedale di Verona Borgo Trento; 🇮🇹 Verona, Italy

Base HEMS Cuneo-Levaldigi; 🇮🇹 Cuneo, Italy

Ospedale Careggi Firenze; 🇮🇹 Firenze, Italy

Ospedale di Siena, Ospedale di Pisa; 🇮🇹 Massa, Italy

Pieve di Cadore HEMS base; 🇮🇹 Pieve Di Cadore, Italy

Ospedale di Torino; 🇮🇹 Torino, Italy

Base HEMS Borgo Sesia; 🇮🇹 Borgosesia, Italy

Treviso hospital; 🇮🇹 Treviso, Italy

Udine FVG; 🇮🇹 Udine, Italy