Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma

Completed

• Conditions: Coagulation Disorder; Coagulation Factor Deficiency; Multiple Trauma; Coagulation Defect; Acquired
• Interventions: Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity

• Registration Number: NCT03634215
• Lead Sponsor: Masaryk Hospital Krajská zdravotní a.s.

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Study Start: 2018-09-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-31
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Trauma patients	fibrinogen plasma concentration, coagulation factor XIII activity	-

Primary Outcome Measures

Name	Time	Method
coagulation factor XIII activity	1 day	coagulation factor XIII activity expressed as % of the normal value

Trial Locations

Locations (3)

Fakultní nemocnice Plzen; 🇨🇿 Plzen, Plzensky Kraj, Czechia

Krajska nemocnice Liberec; 🇨🇿 Liberec, Liberecký Kraj, Czechia

Masarykova nemocnice v Ústí nad Labem; 🇨🇿 Ústí Nad Labem, Ústecký Kraj, Czechia