NCT03572309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

June 19, 2018

Last Update Submit

May 11, 2025

Conditions

TraumaHemorrhageCoagulopathy

Keywords

trauma induced coagulopathymultiple traumafibrinogen

Outcome Measures

Primary Outcomes (1)

  • Trauma induced coagulopathy

    Incidence of trauma induced coagulopathy

    day of enrolment

Secondary Outcomes (2)

  • 28day mortality

    28 days after enrolment

  • thromboembolic complications

    28 days after enrolment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • multiple trauma, injury severity score (ISS) ≥16
  • administration of fibrinogen in prehospital care
  • age 18-80 years

You may not qualify if:

  • ISS 75
  • pregnancy
  • therapeutic anticoagulation
  • therapeutic antiaggregation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno and Masaryk University Brno

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Wounds and InjuriesHemorrhageHemostatic DisordersMultiple Trauma

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Roman Gal, MD, PhD

    Masaryk University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

June 28, 2018

Study Start

June 19, 2018

Primary Completion

April 4, 2023

Study Completion

May 1, 2023

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)