Prehospital Management of Hypotensive Trauma in HEMS (SPITFIRE)

Azienda Usl di Bologna

Status: Enrolling

Conditions: Critical Care; Emergencies; Hypotension and Shock; Wounds and Injuries

Treatments: Device: Prehospital eFAST; Biological: Blood transfusions; Device: Resuscitative endovascular balloon occlusion of the aorta; Drug: Drugs administration; Other: Prehospital management

Study type: Observational

Funder types: Other

Identifiers

NCT04760977

959-2020-OSS-AUSLBO

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Trauma patients in shock

Description:

The study focuses on hypotensive trauma patients assisted by HEMS teams

Treatment:

Other: Prehospital management

Drug: Drugs administration

Biological: Blood transfusions

Device: Resuscitative endovascular balloon occlusion of the aorta

Device: Prehospital eFAST