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Factor XIII in Major Burns Coagulation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03188913
Enrollment
20
Registered
2017-06-16
Start date
2017-06-19
Completion date
2019-07-21
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Burns, Coagulation, Factor XIII, Glycocalix, Cicatrization

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.

Interventions

DIAGNOSTIC_TESTCoagulation 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

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Factor XIII30 daysBlood Coagulation Factor XIII levels

Secondary

MeasureTime frameDescription
Activated Partial Thromboplastin Time (APTT)30 daysActivated Partial Thromboplastin Time blood levels
Thrombin Time (TT)30 daysThrombin Time blood levels
Fibrinogen30 daysFunctional fibrinogen blood levels
Lactate30 daysLactate blood levels
Base Excess (BE)30 daysBase Excess blood levels
Fibrin monomers30 daysFibrin monomers blood levels
Factor XII30 daysFactor XII blood levels
Factor VIII30 daysFactor VIII blood levels
Factor von Willebrand30 daysFactor von Willebrand blood levels
Plasmin30 daysPlasmin blood levels
Plasminogen30 daysPlasminogen blood levels
Prothrombin Time (PT)30 daysProthrombin Time blood levels
Antithrombin (AT)30 daysAntithrombin blood levels
Protein C30 daysProtein C blood levels
Heparan sulfate30 daysHeparan sulfate blood levels
Syndecan 130 daysSyndecan 1 blood levels
Healing Vancouver test30 daysThe Vancouver survey will be conducted on the state of healing
Healing POSAS test30 daysThe POSAS survey will be conducted on the state of healing
Tewamether moisture titration30 daysTewamether consists of two pairs of sensors to measure the humidity and temperature gradients in two different spacings
Surgical bleeding survey10 daysA surgical team survey will be performed on intraoperative bleeding (during the first debridal surgery)
Reintervention due to bleeding11 daysThe need of reintervention because of bleeding within the next 24 hours after the first debridal surgery will be registered
Surface debrided10 daysThe percentage of debrided surface and type of debridement (in the first debriding surgery)
Surgery Bleeding15 daysEstimated bleeding according to the modified Gross formula (in the first debriding surgery)
Alpha-2-antiplasmin30 daysAlpha-2-antiplasmin blood levels

Contacts

Primary ContactPatricia Guilabert, MD
patricia.guilabert@gmail.com0034934 89 30 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026