Health TrialsbyHealthPanel

Prehospital Management of Hypotensive Trauma in HEMS

ConditionsHypotension and ShockWounds and InjuriesEmergenciesCritical Care
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Usl di Bologna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Witnessed traumatic event managed by HEMS

Shock at first evaluation (Systolic blood pressure < 90 mmHg)

Suspect or obvious ongoing haemorrage

Disqualifiers

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

Trial population

The population object of study is represented by all the trauma patients managed by the HEMS crew that are experiencing a probable or obvious haemorragic shock

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Drugs administration

    Drug

    Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents

  • Resuscitative endovascular balloon occlusion of the aorta

    Device

    Resuscitative technique for exsanguinating traumas

  • Blood transfusions

    Biological/Vaccine

    Transfuion of transported blood products for exsanguinating traumas

  • Prehospital management

    Other intervention

    Stay and play strategy vs scoop and run

  • Prehospital eFAST

    Device

    Prehospital thorax/abdomen extended focused assessment sonography for trauma

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Trauma patients in shock5 interventions

Trial outcomes

Primary outcomes

1

30 days mortality

Time frame
30 days

Secondary outcomes

1

survival from prehospital to hospital admmission

Time frame
1 day
2

Hospital length of stay

Time frame
6 months
3

Blood products transfused during the first 24 hours after hospital admission

Time frame
24 hours
4

Transport time

time from dispatch to hospital admission (if any)

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Usl di Bologna

Lead sponsor

Source ClinicalTrials.gov
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