Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

Completed

• Conditions: Hemorrhage; Trauma; Coagulopathy

• Registration Number: NCT03572309
• Lead Sponsor: Masaryk University

Brief Summary

The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

Detailed Description

The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department during the study will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. After admission to emergency department the blood samples will be taken and blood tests and viscoelastic tests will be performed. All data and results will be entered in the study form. Statistical analysis will be performed and incidence of trauma induced coagulopathy estimated. In addition, 28-day mortality and the incidence of thromboembolic complications will be monitored.

Study Timeline

• Study Start: 2018-06-19
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-28
• Primary Completion: 2023-04-04
• Study Completion: 2023-05-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• multiple trauma, injury severity score (ISS) ≥16
• administration of fibrinogen in prehospital care
• age 18-80 years

Exclusion Criteria

• ISS 75
• pregnancy
• therapeutic anticoagulation
• therapeutic antiaggregation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trauma induced coagulopathy	day of enrolment	Incidence of trauma induced coagulopathy

Secondary Outcome Measures

Name	Time	Method
28day mortality	28 days after enrolment
thromboembolic complications	28 days after enrolment

Trial Locations

Locations (1)

University Hospital Brno and Masaryk University Brno; 🇨🇿 Brno, Czechia