Implementation of an Empiric Transfusion Bundle for Out of Hospital Patients With Haemorrhagic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Haemorrhagic Shock, Trauma Coagulopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Primary outcome measures
- Number of patients with successful prehospital bundle transfusion [Time frame: prehospital setting]
Secondary outcome measures (3)
- 30-day-mortality [Time frame: 30 days]
- blood product used in the first 24 hours [Time frame: 24 hours]
- concentration of lactat acid ad admission [Time frame: 2 hours]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Medical University of Graz — Graz
Identifiers
NCT: NCT06891131 · 1032/2025