Prehospital Management of Hypotensive Trauma in HEMS

Study Overview
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Brief Summary
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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

Official Title
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Prehospital Management of Hypotensive Trauma in HEMS

Conditions
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Hypotension and Shock, Wounds and Injuries, Emergencies, Critical Care

Intervention / Treatment
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* Drug: Drugs administration
* Device: Resuscitative endovascular balloon occlusion of the aorta
* Biological: Blood transfusions
* Other: Prehospital management
* Device: Prehospital eFAST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trauma patients in shock<br>The study focuses on hypotensive trauma patients assisted by HEMS teams | Drug: Drugs administration<br>* Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents<br>Device: Resuscitative endovascular balloon occlusion of the aorta<br>* Resuscitative technique for exsanguinating traumas<br>* Other names: REBOA;Biological: Blood transfusions<br>* Transfuion of transported blood products for exsanguinating traumas<br>Other: Prehospital management<br>* Stay and play strategy vs scoop and run<br>Device: Prehospital eFAST<br>* Prehospital thorax/abdomen extended focused assessment sonography for trauma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days mortality |  | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transportation of Patients, Wounds and Injuries, Emergencies, Critical Care