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

Sponsor
Masaryk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03572309
Collaborator
Brno University Hospital (Other)
20
Enrollment
1
Location
41.3
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen
    Actual Study Start Date :
    Jul 23, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Trauma induced coagulopathy [day of enrolment]

      Incidence of trauma induced coagulopathy

    Secondary Outcome Measures

    1. 28day mortality [28 days after enrolment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Brno and Masaryk University Brno Brno Czechia 62500

    Sponsors and Collaborators

    • Masaryk University
    • Brno University Hospital

    Investigators

    • Study Chair: Roman Gal, MD, PhD, Masaryk University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masaryk University
    ClinicalTrials.gov Identifier:
    NCT03572309
    Other Study ID Numbers:
    • CT0022018
    First Posted:
    Jun 28, 2018
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Masaryk University
    trauma induced coagulopathy
    multiple trauma
    fibrinogen
    Additional relevant MeSH terms:
    Hemostatic Disorders
    Blood Coagulation Disorders
    Hemorrhage
    Wounds and Injuries

    Study Results

    No Results Posted as of Mar 3, 2021