Clinical trial NCT06891131: Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Haemorrhagic Shock
Trauma Coagulopathy
Keywords: Trauma
coagulopathy
haemmorhage
transfusion
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in haemorrhagic shock that are being treated by one of the prehospital emergency systems of the Medical University of Graz (HEMS, emergency car)

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

Eligibility 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.

Primary outcomes:
measure: Number of patients with successful prehospital bundle transfusion
timeFrame: prehospital setting
Secondary outcomes:
measure: 30-day-mortality
timeFrame: 30 days
measure: blood product used in the first 24 hours
timeFrame: 24 hours
measure: concentration of lactat acid ad admission
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Graz, Department of Anaesthesiology
name: Gabriel Honnef, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: