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NCT03572309 Clinical Trial

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

Trauma Clinical Trial

— TICAF  

Official title:
Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03572309
Other study ID # CT0022018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 23, 2018
Est. completion date December 2023

Study information
Verified date March 2023
Source Masaryk University
Contact Kamil Vrbica, MD
Phone +420532233850
Email Vrbica.Kamil@fnbrno.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department from the 1st of July 2018 to the 30st of June 2020 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. 28-day mortality will be also monitored.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Czechia University Hospital Brno and Masaryk University Brno Brno

Sponsors (2)
Lead Sponsor Collaborator
Masaryk University Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Trauma induced coagulopathy Incidence of trauma induced coagulopathy day of enrolment
Secondary 28day mortality 28 days after enrolment
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