Prehospital Management of Hypotensive Trauma in HEMS (SPITFIRE)

August 10, 2024 updated by: Azienda Usl di Bologna

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • Recruiting
        • Ospedale di Alessandria
        • Contact:
          • Andrea Mina
        • Contact:
          • Simona Cavallo
      • Aosta, Italy
        • Not yet recruiting
        • Base HEMS Aosta
        • Contact:
          • Andrea Caglià
      • Bologna, Italy
        • Not yet recruiting
        • Ospedale di Bolzano
        • Contact:
          • Francesca Verginella
      • Borgosesia, Italy
        • Not yet recruiting
        • Base HEMS Borgo Sesia
        • Contact:
          • Andrea Mina
        • Contact:
          • Simona Cavallo
      • Cuneo, Italy
        • Not yet recruiting
        • Base HEMS Cuneo-Levaldigi
        • Contact:
          • Andrea Mina
        • Contact:
          • Simona Cavallo
      • Firenze, Italy
        • Not yet recruiting
        • Ospedale Careggi Firenze
        • Contact:
          • Mario Rugna
      • Grosseto, Italy
        • Recruiting
        • Ospedale di Siena, Ospedale di Pisa
        • Contact:
          • Giovanni Sbrana
      • Massa, Italy
        • Not yet recruiting
        • Ospedale di Siena, Ospedale di Pisa
        • Contact:
          • Silvia Pini
        • Contact:
          • Andrea Vignali
      • Padova, Italy
        • Not yet recruiting
        • Ospedale di Padova
        • Contact:
          • Andrea Paoli
      • Pavullo Nel Frignano, Italy
      • Pieve Di Cadore, Italy
      • Torino, Italy
        • Not yet recruiting
        • Ospedale di Torino
        • Contact:
          • Andrea Mina
        • Contact:
          • Simona Cavallo
      • Trento, Italy
        • Not yet recruiting
        • Base HEMS Trento
        • Contact:
          • Vittorio Albarello
      • Treviso, Italy
      • Udine, Italy
      • Verona, Italy
        • Not yet recruiting
        • Ospedale di Verona Borgo Trento
        • Contact:
          • Giacomo Magagnotti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trauma patients in shock
The study focuses on hypotensive trauma patients assisted by HEMS teams
Drug: Drugs administration
Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents
Device: Resuscitative endovascular balloon occlusion of the aorta
Resuscitative technique for exsanguinating traumas
Other Names:
  • REBOA
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30 days mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Usl di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 10, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 959-2020-OSS-AUSLBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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