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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | April 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | December 17, 2025 |
| Trial ID | NCT06891131 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
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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
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Simplified Tranexamic Acid Regimen for Trauma with Hemorrhage
This trial tests a simplified TXA dosing approach to see if it safely helps adults with major trauma and significant bleeding.
-
Stability of blood clotting products in ambulances under real-world conditions
This study checks whether fibrinogen concentrates and Octaplas plasma stay stable when stored in real EMS ambulances in Graz, Austria.
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Rapid bedside fibrinogen testing for bleeding trauma patients in the emergency department
This will test a rapid bedside fibrinogen test for adults with traumatic bleeding to help decide who needs fibrinogen replacement.
-
Using ROTEM analysis to improve outcomes in sepsis and trauma patients
This study is testing if a special blood test can help doctors spot early signs of serious blood clotting issues in patients with sepsis or trauma to improve their treatment.
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Using tranexamic acid to treat traumatic bleeding with real-time monitoring
This study tests whether giving tranexamic acid in a new way, based on real-time blood monitoring, can help patients with severe trauma stop bleeding better and reduce the risk of complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.