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

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ClinicalTrials.gov Identifier: NCT03634215
Recruitment Status : Unknown
Verified August 2018 by Josef Skola, Masaryk Hospital Krajská zdravotní a.s..
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Josef Skola, 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.

Condition or disease Intervention/treatment
Multiple Trauma Coagulation Disorder Coagulation Factor Deficiency Coagulation Defect; Acquired Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Multiple Trauma patients Diagnostic Test: fibrinogen plasma concentration, coagulation factor XIII activity
blood sampling for a routine coagulation test




Primary Outcome Measures :
  1. coagulation factor XIII activity [ Time Frame: 1 day ]
    coagulation factor XIII activity expressed as % of the normal value



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with presumed severe trauma as assessed by the national trauma triage criteria admitted to a participating centre.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634215


Contacts
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Contact: Josef Skola, MUDr +420477114060 josef.skola@kzcr.eu

Sponsors and Collaborators
Masaryk Hospital Krajská zdravotní a.s.
Publications:
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Responsible Party: Josef Skola, Clinical Director, Masaryk Hospital Krajská zdravotní a.s.
ClinicalTrials.gov Identifier: NCT03634215    
Other Study ID Numbers: KAPIM-2
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Multiple Trauma
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders