NCT04760977

Prehospital Management of Hypotensive Trauma in HEMS

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypotension and Shock
• Wounds and Injuries
• Emergencies
• Critical Care

Interventions

Type	Name	Description
DRUG	Drugs administration	Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents
DEVICE	Resuscitative endovascular balloon occlusion of the aorta	Resuscitative technique for exsanguinating traumas
BIOLOGICAL	Blood transfusions	Transfuion of transported blood products for exsanguinating traumas
OTHER	Prehospital management	Stay and play strategy vs scoop and run
DEVICE	Prehospital eFAST	Prehospital thorax/abdomen extended focused assessment sonography for trauma

Timeline

• Start date: 2021-05-01
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2021-02-18
• Last updated: 2024-08-13

Locations

16 sites across 1 country: Italy