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Completed

NCT Number: NCT03572309

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

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.

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Key information

Conditions

Trauma Cardiovascular Diseases Coagulopathy Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Multiple Trauma Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Brno and Masaryk University Brno

Brno, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Trauma induced coagulopathy

    Time frame: day of enrolment

    Incidence of trauma induced coagulopathy

Secondary outcomes

  1. 28day mortality

    Time frame: 28 days after enrolment

  2. thromboembolic complications

    Time frame: 28 days after enrolment

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Collaborators

  • Brno University Hospital

Registry information

Acronym: TICAF

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2018
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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