Factor XIII in Major Burns Coagulation

Study Overview
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Brief Summary
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Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.

Detailed Description
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This is a prospective observational pilot study in which the levels of FXIII and coagulation, anticoagulation, fibrinolysis, endothelial tissue damage and cicatrization are at the arrival of the patient to hospital, 24 hours before the first surgical intervention, 24h After the first surgical intervention, at 7 days after the first intervention and at 30 days after the thermal trauma, in this moment the healing will also be evaluated. All burn patients who meet the proposed inclusion criteria will be included and entered into the Burn Unit of the Vall d'Hebron University Hospital from the start of the study until reaching a minimum of 20 cases or a temporary term of 2 years.

Official Title
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Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study

Conditions
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Burns, Coagulation Disorder, Factor XIII Deficiency, Cicatrization, Endothelial Dysfunction

Intervention / Treatment
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* Diagnostic Test: Coagulation tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Burned patients with a burned body surface of 20% or more Over 18 years of age Exclusion Criteria: ABSI (Abbreviated Burns Severity Index) greater than or equal to 12 Associated polytrauma Coagulation deficit previously known Treatment with anticoagulants Electrocution burns Admission into the unit after hour 6 after thermal trauma The refusal of the patient, familiar or responsible to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Coagulation tests|The following plasma values will be measured: prothrombin time, activated partial thromboplastin time, thrombin time, functional fibrinogen, lactate, base excess, fibrin monomers, Factor XIII, Factor XII, Factor VIII, Fact von Willebrand, Plasmin, Plasminogen, Alpha-2-antiplasmin, antithrombin, protein C, Heparan sulfate, synecan 1. Surveys on the state of healing and moisture titration will be performed using Tewamether|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factor XIII | Blood Coagulation Factor XIII levels | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prothrombin Time (PT) | Prothrombin Time blood levels | 30 days | 
| Activated Partial Thromboplastin Time (APTT) | Activated Partial Thromboplastin Time blood levels | 30 days | 
| Thrombin Time (TT) | Thrombin Time blood levels | 30 days | 
| Fibrinogen | Functional fibrinogen blood levels | 30 days | 
| Lactate | Lactate blood levels | 30 days | 
| Base Excess (BE) | Base Excess blood levels | 30 days | 
| Fibrin monomers | Fibrin monomers blood levels | 30 days | 
| Factor XII | Factor XII blood levels | 30 days | 
| Factor VIII | Factor VIII blood levels | 30 days | 
| Factor von Willebrand | Factor von Willebrand blood levels | 30 days | 
| Plasmin | Plasmin blood levels | 30 days | 
| Plasminogen | Plasminogen blood levels | 30 days | 
| Alpha-2-antiplasmin | Alpha-2-antiplasmin blood levels | 30 days | 
| Antithrombin (AT) | Antithrombin blood levels | 30 days | 
| Protein C | Protein C blood levels | 30 days | 
| Heparan sulfate | Heparan sulfate blood levels | 30 days | 
| Syndecan 1 | Syndecan 1 blood levels | 30 days | 
| Healing Vancouver test | The Vancouver survey will be conducted on the state of healing | 30 days | 
| Healing POSAS test | The POSAS survey will be conducted on the state of healing | 30 days | 
| Tewamether moisture titration | Tewamether consists of two pairs of sensors to measure the humidity and temperature gradients in two different spacings | 30 days | 
| Surgical bleeding survey | A surgical team survey will be performed on intraoperative bleeding (during the first debridal surgery) | 10 days | 
| Reintervention due to bleeding | The need of reintervention because of bleeding within the next 24 hours after the first debridal surgery will be registered | 11 days | 
| Surface debrided | The percentage of debrided surface and type of debridement (in the first debriding surgery) | 10 days | 
| Surgery Bleeding | Estimated bleeding according to the modified Gross formula (in the first debriding surgery) | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Coagulation, Factor XIII, Glycocalix, Cicatrization