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

Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634215
• Other study ID #: KAPIM-2
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2022
• Source: Masaryk Hospital Krajská zdravotní a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defect; Acquired
• Coagulation Disorder
• Coagulation Factor Deficiency
• Hemostatic Disorders
• Multiple Trauma
• Wounds and Injuries

Intervention

Diagnostic Test:
• fibrinogen plasma concentration, coagulation factor XIII activity
blood sampling for a routine coagulation test

Locations

Country	Name	City	State
Czechia	Krajska nemocnice Liberec	Liberec	Liberecký Kraj
Czechia	Fakultní nemocnice Plzen	Plzen	Plzensky Kraj
Czechia	Masarykova nemocnice v Ústí nad Labem	Ústí Nad Labem	Ústecký Kraj

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk Hospital Krajská zdravotní a.s.

Country where clinical trial is conducted

Czechia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coagulation factor XIII activity	coagulation factor XIII activity expressed as % of the normal value	1 day