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Factor XIII in Major Burns Coagulation

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ClinicalTrials.gov Identifier: NCT03188913
Recruitment Status : Not yet recruiting
First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Burns Coagulation Disorder Factor XIII Deficiency Cicatrization Endothelial Dysfunction Diagnostic Test: Coagulation tests

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Major Burns Coagulation and the Role of Factor XIII: A Descriptive Study
Estimated Study Start Date : June 19, 2017
Estimated Primary Completion Date : June 19, 2019
Estimated Study Completion Date : July 21, 2019



Intervention Details:
  • 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
    Other Name: Cicatrization tests


Primary Outcome Measures :
  1. Factor XIII [ Time Frame: 30 days ]
    Blood Coagulation Factor XIII levels


Secondary Outcome Measures :
  1. Prothrombin Time (PT) [ Time Frame: 30 days ]
    Prothrombin Time blood levels

  2. Activated Partial Thromboplastin Time (APTT) [ Time Frame: 30 days ]
    Activated Partial Thromboplastin Time blood levels

  3. Thrombin Time (TT) [ Time Frame: 30 days ]
    Thrombin Time blood levels

  4. Fibrinogen [ Time Frame: 30 days ]
    Functional fibrinogen blood levels

  5. Lactate [ Time Frame: 30 days ]
    Lactate blood levels

  6. Base Excess (BE) [ Time Frame: 30 days ]
    Base Excess blood levels

  7. Fibrin monomers [ Time Frame: 30 days ]
    Fibrin monomers blood levels

  8. Factor XII [ Time Frame: 30 days ]
    Factor XII blood levels

  9. Factor VIII [ Time Frame: 30 days ]
    Factor VIII blood levels

  10. Factor von Willebrand [ Time Frame: 30 days ]
    Factor von Willebrand blood levels

  11. Plasmin [ Time Frame: 30 days ]
    Plasmin blood levels

  12. Plasminogen [ Time Frame: 30 days ]
    Plasminogen blood levels

  13. Alpha-2-antiplasmin [ Time Frame: 30 days ]
    Alpha-2-antiplasmin blood levels

  14. Antithrombin (AT) [ Time Frame: 30 days ]
    Antithrombin blood levels

  15. Protein C [ Time Frame: 30 days ]
    Protein C blood levels

  16. Heparan sulfate [ Time Frame: 30 days ]
    Heparan sulfate blood levels

  17. Syndecan 1 [ Time Frame: 30 days ]
    Syndecan 1 blood levels

  18. Healing Vancouver test [ Time Frame: 30 days ]
    The Vancouver survey will be conducted on the state of healing

  19. Healing POSAS test [ Time Frame: 30 days ]
    The POSAS survey will be conducted on the state of healing

  20. Tewamether moisture titration [ Time Frame: 30 days ]
    Tewamether consists of two pairs of sensors to measure the humidity and temperature gradients in two different spacings

  21. Surgical bleeding survey [ Time Frame: 10 days ]
    A surgical team survey will be performed on intraoperative bleeding (during the first debridal surgery)

  22. Reintervention due to bleeding [ Time Frame: 11 days ]
    The need of reintervention because of bleeding within the next 24 hours after the first debridal surgery will be registered

  23. Surface debrided [ Time Frame: 10 days ]
    The percentage of debrided surface and type of debridement (in the first debriding surgery)

  24. Surgery Bleeding [ Time Frame: 15 days ]
    Estimated bleeding according to the modified Gross formula (in the first debriding surgery)


Biospecimen Retention:   Samples Without DNA
Blood


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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:   Non-Probability Sample
Study Population
Burned patients over 18 years of age with a burned body surface of 20% or more admitted to the burn unit of the Vall d'Hebron University Hospital from the start of the study to the end of the study with surgical burns ( Second grade or third grade) and for whom informed consent has been obtained
Criteria

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

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): NCT03188913


Contacts
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Contact: Patricia Guilabert, MD 0034934 89 30 00 ext 3504 patricia.guilabert@gmail.com

Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Patricia Guilabert, MD Vall d'Hebron Universitary Hospital

Publications:

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03188913     History of Changes
Other Study ID Numbers: PR(ATR)341/2016
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Burns
Coagulation
Factor XIII
Glycocalix
Cicatrization

Additional relevant MeSH terms:
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Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Burns
Factor XIII Deficiency
Cicatrix
Wounds and Injuries
Fibrosis
Pathologic Processes