Factor XIII in Major Burns Coagulation

• Conditions: Cicatrization; Burns; Endothelial Dysfunction; Coagulation Disorder; Factor XIII Deficiency

• Registration Number: NCT03188913
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-15
• Last Update Submitted: 2017-06-15
• Study First Posted: 2017-06-16
• Last Update Posted: 2017-06-16
• Study Start: 2017-06-19
• Primary Completion: 2019-06-19
• Study Completion: 2019-07-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Factor XIII	30 days	Blood Coagulation Factor XIII levels

Secondary Outcome Measures

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