Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock (C-TOP)

Medical University of Graz

Status: Enrolling

Conditions: Trauma Coagulopathy; Haemorrhagic Shock

Study type: Observational

Funder types: Other

Identifiers

NCT06891131

1032/2025

Details and patient eligibility

About

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

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.