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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Trauma patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fibrinogen plasma concentration, coagulation factor XIII activity | Diagnostic Test | blood sampling for a routine coagulation test |
|
| Measure | Description | Time Frame |
|---|---|---|
| coagulation factor XIII activity | coagulation factor XIII activity expressed as % of the normal value | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with presumed severe trauma as assessed by the national trauma triage criteria admitted to a participating centre.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krajska nemocnice Liberec | Liberec | Liberec Region | 46001 | Czechia | ||
| Fakultní nemocnice Plzen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25652913 | Background | 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. | |
| 25545751 | Background | 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. |
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| Pilsen |
| Plzeň Region |
| 30100 |
| Czechia |
| Masarykova nemocnice v Ústí nad Labem | Ústí nad Labem | Ústí nad Labem Region | 40001 | Czechia |
| 22441854 | Background | 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. |
| ID | Term |
|---|---|
| D009104 | Multiple Trauma |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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