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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06891131

Acronym

C-TOP

Enrollment

Registered

2025-03-24

Start date

2025-06-01

Completion date

2027-06-01

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemorrhagic Shock, Trauma Coagulopathy

Keywords

Trauma, coagulopathy, haemmorhage, transfusion

Brief summary

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with successful prehospital bundle transfusion	prehospital setting	to assess feasibility

Secondary

Measure	Time frame	Description
30-day-mortality	30 days	—
blood product used in the first 24 hours	24 hours	—
concentration of lactat acid ad admission	2 hours	measured in the emergency department

Countries

Austria

Contacts

Primary ContactGabriel Honnef, MD, PhD

gabriel.honnef@medunigraz.at+436509160890

Outcome results