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

NCT ID: NCT03572309

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-19

Study Completion Date

2023-05-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Trauma Hemorrhage Coagulopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brno University Hospital

OTHER

Sponsor Role collaborator

Masaryk University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roman Gal, MD, PhD

Role: STUDY_CHAIR

Masaryk University

Locations

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University Hospital Brno and Masaryk University Brno

Brno, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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CT0022018

Identifier Type: -

Identifier Source: org_study_id

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