NCT03634215

Brief Summary

Coagulation factor XIII (FXIII), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. It also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. It has been found that similar to plasma fibrinogen level, FXIII activity can be reduced in the early phase of severe trauma. Therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. However, unlike plasma fibrinogen level evaluation, measurement of the FXIII activity is not routinely available. Therefore, targeted substitution of FXIII is practically impossible. The plasma fibrinogen level is routinely measured in severe trauma patients. Based on pathophysiologic assumptions and a limited number of published data we hypothesize that the FXIII activity correlates with fibrinogen level. In such case, indirect FXIII activity prediction by fibrinogen level measurement would be a convenient approach to enable FXIII targeted substitution. Therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased FXIII activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

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

July 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

July 1, 2018

Last Update Submit

December 31, 2022

Conditions

Multiple TraumaCoagulation DisorderCoagulation Factor DeficiencyCoagulation Defect; Acquired

Outcome Measures

Primary Outcomes (1)

  • coagulation factor XIII activity

    coagulation factor XIII activity expressed as % of the normal value

    1 day

Study Arms (1)

Multiple Trauma patients

Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity

Interventions

fibrinogen plasma concentration, coagulation factor XIII activityDIAGNOSTIC_TEST

blood sampling for a routine coagulation test

Multiple Trauma patients

Eligibility Criteria

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

All patients with presumed severe trauma as assessed by the national trauma triage criteria admitted to a participating centre.

You may qualify if:

  • a patient with presumed severe trauma admitted to the participating centre

You may not qualify if:

  • inflammatory disease
  • malignant disease
  • pregnancy
  • receipt of any fibrinogen / coagulation factor XIII product before blood sampling
  • patients on dabigatran

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Krajska nemocnice Liberec

Liberec, Liberecký kraj, 46001, Czechia

Location

Fakultní nemocnice Plzen

Pilsen, Plzeň Region, 30100, Czechia

Location

Masarykova nemocnice v Ústí nad Labem

Ústí nad Labem, Ústecký kraj, 40001, Czechia

Location

Related Publications (3)

  • Dickneite G, Herwald H, Korte W, Allanore Y, Denton CP, Matucci Cerinic M. Coagulation factor XIII: a multifunctional transglutaminase with clinical potential in a range of conditions. Thromb Haemost. 2015 Apr;113(4):686-97. doi: 10.1160/TH14-07-0625. Epub 2015 Feb 5.

    PMID: 25652913BACKGROUND

  • Theusinger OM, Baulig W, Seifert B, Muller SM, Mariotti S, Spahn DR. Changes in coagulation in standard laboratory tests and ROTEM in trauma patients between on-scene and arrival in the emergency department. Anesth Analg. 2015 Mar;120(3):627-635. doi: 10.1213/ANE.0000000000000561.

    PMID: 25545751BACKGROUND

  • Sorensen B, Fries D. Emerging treatment strategies for trauma-induced coagulopathy. Br J Surg. 2012 Jan;99 Suppl 1:40-50. doi: 10.1002/bjs.7770.

    PMID: 22441854BACKGROUND

MeSH Terms

Conditions

Multiple TraumaHemostatic Disorders

Condition Hierarchy (Ancestors)

Wounds and InjuriesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

July 1, 2018

First Posted

August 16, 2018

Study Start

September 1, 2018

Primary Completion

January 31, 2019

Study Completion

March 31, 2019

Last Updated

January 4, 2023

Record last verified: 2022-12

Locations

CZ(3)