Clinical trial Recruiting at 1 site Observational Ages 18 and up

Empiric prehospital transfusion bundle for traumatic haemorrhagic shock

Official title: Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock: a Prospective Observational Study C-TOP - Coagulation Therapy for Out-of-Hospital Patients

Run by Medical University of Graz · NCT06891131 · Data updated 2026-11-12

We will try giving fibrinogen, plasma, and tranexamic acid before hospital arrival to adults with suspected life‑threatening bleeding from trauma to see if outcomes and safety change.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorMedical University of Graz
Academic / other
Locations1 site (Graz)
StatusRecruiting
StartedJune 1, 2025
Main results expectedApril 1, 2027
Study endsJune 1, 2027
Registry record updatedDecember 17, 2025
Trial IDNCT06891131 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18 years or older) with confirmed or suspected life‑threatening bleeding from trauma who receive prehospital transfusion and are transported to the Medical University of Graz resuscitation room.

Probably not a fit

Patients with a recent history of thromboembolic events (within 6 months), known or suspected pregnancy, those who refuse participation, or trauma patients who do not receive prehospital transfusion or are not brought to the Graz resuscitation room are unlikely to benefit from this implemented bundle.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational implementation of a prehospital transfusion bundle delivered by the Medical University of Graz emergency doctor response team and the Graz HEMS. Only adults with suspected life‑threatening traumatic bleeding who receive prehospital transfusion and are transported to the resuscitation room at the Medical University of Graz will be included. The bundled intervention follows local SOPs and consists of two units of fibrinogen and plasma plus tranexamic acid at 10–20 mg/kg. The project aims to collect real‑world data on benefits and harms after introducing this change to prehospital routine care.

Why it matters

Potential benefit: If successful, earlier delivery of fibrinogen, plasma, and tranexamic acid before hospital arrival could reduce bleeding, lower subsequent transfusion needs, and improve survival or recovery for patients with traumatic haemorrhagic shock.

How similar studies have gone: Components such as tranexamic acid and prehospital plasma have shown benefit or mixed results in prior studies, but combining fibrinogen, plasma, and TXA as a routine prehospital bundle is relatively novel and not yet proven in randomized trials.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Medical University of Graz
    Graz, Austria
    Recruiting

Study contacts

  • Principal investigator: Gabriel Honnef, MD, PhD — Medical University of Graz, Department of Anaesthesiology
  • Study coordinator: Gabriel Honnef, MD, PhD
  • Email: gabriel.honnef@medunigraz.at
  • Phone: +436509160890

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.