NCT06891131

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
13mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

March 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

March 17, 2025

Last Update Submit

December 9, 2025

Conditions

Haemorrhagic ShockTrauma Coagulopathy

Keywords

Traumacoagulopathyhaemmorhagetransfusion

Outcome Measures

Primary Outcomes (1)

  • Number of patients with successful prehospital bundle transfusion

    to assess feasibility

    prehospital setting

Secondary Outcomes (3)

  • 30-day-mortality

    30 days

  • blood product used in the first 24 hours

    24 hours

  • concentration of lactat acid ad admission

    2 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • aged, or believed to be aged
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8043, Austria

RECRUITING

MeSH Terms

Conditions

Shock, HemorrhagicWounds and InjuriesHemostatic Disorders

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShockVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Gabriel Honnef, MD, PhD

    Medical University of Graz, Department of Anaesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Honnef, MD, PhD

CONTACT

+436509160890gabriel.honnef@medunigraz.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 24, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

December 17, 2025

Record last verified: 2025-03

Locations

AU(1)