Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock

NCT ID: NCT06891131

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-06-01

Brief Summary

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The investigators will evaluate the implementation of a treatment bundle (Fibrinogen, Plasma and Tranexamic Acid)

Detailed Description

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The investigators will perform a prospective observational study of patients in haemorrhagic shock with suspected life threatening bleeding from trauma, treated by the prehospital emergency doctor response team of the Medical University of Graz and the HEMS (Helicopter Emergency Medical Service) of Graz according to their SOPs. Only patients that are being transported to the resuscitation room of the Medical University of Graz after prehospital transfusion will be included.

The SOPs for prehospital transfusion are being implemented for the treatment of patients in extremis because of suspected life-threatening traumatic bleeding in the above-mentioned emergency services, according to the manufacturer's requirements. These transfusion SOPs are already part of the standard of care in the resuscitation room of the Medical University of Graz.

This study seeks to gather information on the benefits and potential harms of this change of prehospital clinical routine.

The treatment bundle will include 2 units of Fibrinogen and Plasma in addition to 10-20 mg/kg Tranexamic Acid

Conditions

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Haemorrhagic Shock Trauma Coagulopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* aged, or believed to be aged
* 18 years or above
* confirmed or suspected life-threatening bleeding from trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
* need for volume replacement therapy.

Exclusion Criteria

* patient with known recent history of thromboembolic events within the last 6 months
* known or suspected pregnancy at presentation
* patient with known refusal of a participation in this clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Honnef, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Department of Anaesthesiology

Locations

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Medical University of Graz

Graz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Gabriel Honnef, MD, PhD

Role: CONTACT

+436509160890

Facility Contacts

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Gabriel Honnef, MD, PhD

Role: primary

Other Identifiers

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1032/2025

Identifier Type: -

Identifier Source: org_study_id