Factor XIII in Major Burns Coagulation

Brief Title

Factor XIII in Major Burns Coagulation

Official Title

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

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 Type

Observational


Primary Outcome

Factor XIII

Secondary Outcome

 Prothrombin Time (PT)

Condition

Burns

Intervention

Coagulation tests


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

20

Start Date

June 19, 2017

Completion Date

July 21, 2019

Primary Completion Date

June 19, 2019

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Patricia Guilabert, MD, 0034934 89 30 00, [email protected]



Administrative Informations


NCT ID

NCT03188913

Organization ID

PR(ATR)341/2016


Responsible Party

Sponsor

Study Sponsor

Hospital Universitari Vall d'Hebron Research Institute


Study Sponsor

Patricia Guilabert, MD, Principal Investigator, Vall d'Hebron Universitary Hospital


Verification Date

May 2017