Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen (TICAF)

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhage; Trauma; Coagulopathy

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Kamil Vrbica, MD; Phone Number: +420532233850; Email: Vrbica.Kamil@fnbrno.cz
• Study Contact Backup: Name: Ondrej Hrdy, MD; Phone Number: +420532233850; Email: Hrdy.Ondrej@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital Brno and Masaryk University Brno
    • Contact: Kamil Vrbica, M.D.; Phone Number: +420 532233850; Email: vrbica.kamil@fnbrno.cz
    • Contact: Ondrej Hrdy, M.D.; Phone Number: +420 532232305; Email: hrdy.ondrej@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult trauma patients with severe trauma admitted to emergency departement of university hospital who recieved fibrinogen during prehospital care.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trauma induced coagulopathy	Incidence of trauma induced coagulopathy	day of enrolment

Secondary Outcome Measures

Outcome Measure	Time Frame
28day mortality	28 days after enrolment

Collaborators and Investigators

• Sponsor: Masaryk University
• Collaborators: Brno University Hospital
• Investigators: Study Chair: Roman Gal, MD, PhD, Masaryk University

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: trauma induced coagulopathy; multiple trauma; fibrinogen
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Wounds and Injuries; Hemorrhage
• Other Study ID Numbers: CT0022018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No