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RecruitingNCT06891131C-TOPUpdated Dec 17, 2025

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

An observational study in Haemorrhagic Shock and Trauma Coagulopathy, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Medical University of Graz · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Haemorrhagic Shock
  • Trauma Coagulopathy

Keywords

  • Trauma
  • coagulopathy
  • haemmorhage
  • transfusion
03

In context

Shock, Hemorrhagic

79 studies on the registry are indexed under Shock, Hemorrhagic; 15 are open to participants now.

This study's planned enrollment of 10 is below the median of 113 across 30 observational studies indexed under Shock, Hemorrhagic.

Browse Shock, Hemorrhagic studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients in haemorrhagic shock that are being treated by one of the prehospital emergency systems of the Medical University of Graz (HEMS, emergency car)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of patients with successful prehospital bundle transfusion

    to assess feasibility

    Time frame: prehospital setting

Secondary outcomes

  1. 30-day-mortality

    Time frame: 30 days

  2. blood product used in the first 24 hours

    Time frame: 24 hours

  3. concentration of lactat acid ad admission

    measured in the emergency department

    Time frame: 2 hours

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06891131
Responsible party
Sponsor
First posted
Mar 24, 2025
Start date
Jun 1, 2025
Primary completion
Apr 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Dec 17, 2025

Study contacts

Gabriel Honnef, MD, PhD
Contact
gabriel.honnef@medunigraz.at
+436509160890
Gabriel Honnef, MD, PhD
principal investigator · Medical University of Graz, Department of Anaesthesiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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