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NCT Number: NCT06891131

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8043, Austria

Location status: Recruiting

Location contact

Gabriel Honnef, MD, PhD

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients with successful prehospital bundle transfusion

    Time frame: prehospital setting

    to assess feasibility

Secondary outcomes

  1. 30-day-mortality

    Time frame: 30 days

  2. blood product used in the first 24 hours

    Time frame: 24 hours

  3. concentration of lactat acid ad admission

    Time frame: 2 hours

    measured in the emergency department

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Honnef, MD, PhD

CONTACT

[email protected]

+436509160890

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Acronym: C-TOP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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