NCT04107818

Brief Summary

The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

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

August 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2021

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

August 9, 2019

Last Update Submit

May 21, 2024

Conditions

PolytraumaCoagulation Disorder

Keywords

polytraumacoagulopathyviscoelastic tests

Outcome Measures

Primary Outcomes (10)

  • Clotting time (CT) in EX-test and EXTEM

    difference in clotting time measured by EX-test and EXTEM

    through study completion, an average of 3 months

  • Clot formation time (CFT) in EX-test and EXTEM

    difference in clot formation time measured by EX-test and EXTEM

    through study completion, an average of 3 months

  • alfa angle in EX-test and EXTEM

    difference in alfa angle measured by EX-test and EXTEM

    through study completion, an average of 3 months

  • maximum clot firmness (MCF) in EX-test and EXTEM

    difference in maximum clot firmness measured by EX-test and EXTEM

    through study completion, an average of 3 months

  • maximum lysis (ML) in EX-test and EXTEM

    maximum lysis difference in MCF measured by EX-test and EXTEM

    through study completion, an average of 3 months

  • clotting time (CT) FIB-test and FIBTEM

    difference in clotting time measured by FIB-test and FIBTEM

    through study completion, an average of 3 months

  • clot formation time (CFT) FIB-test and FIBTEM

    difference in clot formation time measured by FIB-test and FIBTEM

    through study completion, an average of 3 months

  • maximum clot firmness (MCF) FIB-test and FIBTEM

    difference in maximum clot firmness measured by FIB-test and FIBTEM

    through study completion, an average of 3 months

  • alfa angle FIB-test and FIBTEM

    difference in alfa angle measured by FIB-test and FIBTEM

    through study completion, an average of 3 months

  • maximum lysis (ML) FIB-test and FIBTEM

    difference in maximum lysis measured by FIB-test and FIBTEM

    through study completion, an average of 3 months

Secondary Outcomes (3)

  • patient temperature

    through study completion, an average of 3 months

  • maximum clot firmness (MCF) FIB-test and Clauss method

    through study completion, an average of 3 months

  • maximum clot firmness (MCF) FIBTEM and Clauss method

    through study completion, an average of 3 months

Eligibility Criteria

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

Adult patients admitted to emnergency department for severe trauma.

You may qualify if:

  • age ≥18 years
  • polytrauma with Injury severity score ≥ 16

You may not qualify if:

  • pregnancy
  • anticoagulant therapy
  • antiplatelet therapy
  • coagulation disorders

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

Multiple TraumaHemostatic Disorders

Condition Hierarchy (Ancestors)

Wounds and InjuriesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Roman Gal, MD., PhD.

    University Hospital Brno and Masaryk University Brno

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 9, 2019

First Posted

September 27, 2019

Study Start

November 21, 2019

Primary Completion

October 13, 2021

Study Completion

October 13, 2021

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)