Empiric prehospital transfusion bundle for traumatic haemorrhagic shock
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
Medical University of Graz · NCT06891131
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 type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz (other) |
| Locations | 1 site (Graz) |
| Trial ID | NCT06891131 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Graz
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Haemorrhagic Shock, Trauma Coagulopathy, Trauma, coagulopathy, haemmorhage, transfusion