An observational study in Multiple Trauma, Coagulation Disorder and Coagulation Factor Deficiency, sponsored by Masaryk Hospital Krajská zdravotní a.s.. Completed at 3 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Masaryk Hospital Krajská zdravotní a.s. · Observational
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.
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.
139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.
This study's enrollment of 357 is above the median of 200 across 84 observational studies indexed under Multiple Trauma.
Browse Multiple Trauma studies →Masaryk Hospital Krajská zdravotní a.s. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with presumed severe trauma as assessed by the national trauma triage criteria admitted to a participating centre.
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Exclusion Criteria:
Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity
blood sampling for a routine coagulation test
coagulation factor XIII activity
coagulation factor XIII activity expressed as % of the normal value
Time frame: 1 day
Plan to share: Undecided
Ran from Sep 2018 to primary completion in Jan 2019, 4 months.
Of 30 observational studies under Multiple Trauma, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's 4 months is below that.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Masaryk Hospital Krajská zdravotní a.s.