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Thrombin Generation in Crohn's Disease

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02445690
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
150
Enrollment
3
Locations
23
Duration (Months)
50
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission, with or without endoscopic activity will be included. Thrombin generation will be measured and correlated with the simplified endoscopic activity score. The patients will be evaluated for development of deep vein thrombosis after one-year of follow-up.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission defined by the Crohn's Disease Activity Index below 150 and Harvey-Bradshaw Index below 5, with or without endoscopic activity defined by simplified endoscopic activity score for Crohn's disease (SES-CD) will be included in this study (75 patients with a complete mucosal healing defined by SES-CD below 3 and 75 with endoscopic activity defined by SES-CD above 6) in multiple centers specializing in the treatment of inflammatory bowel diseases in Brazil; Study data will be collected and managed using REDCap electronic data capture tools hosted at the Clinical Hospital of University of São Paulo. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies. All thrombin generation tests will be performed at the Clinical Hospital of University of São Paulo, São Paulo, SP through automatically calibrated Thrombogram (CAT- Calibrated Automated Thrombogram®, Maastricht, The Netherlands), with and without thrombomodulin. Those patients will be followed for at least one year after the colonoscopy with measurement of the D-dimer and clinical evaluation every 3 months to verify the developing of deep vein thrombosis.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Thrombin Generation and Endoscopic Activity in Crohn's Disease
    Study Start Date :
    May 1, 2015
    Anticipated Primary Completion Date :
    Apr 1, 2017
    Anticipated Study Completion Date :
    Apr 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Clinical remission without inflammation

    Patients with Crohn's disease in clinical remission and no inflammation in the colonoscopy
    Clinical remission with inflammation

    Patients with Crohn's disease in clinical remission and active inflammation in the colonoscopy

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between thrombin generation and endoscopic activity [At the moment of the inclusion]

    Secondary Outcome Measures

    1. Association of a high thrombin generation and development of deep vein thrombosis [After 1 year of follow up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Established Crohn's disease diagnosis for at least 6 months

    • Disease involvement of the terminal ileum and/or colon

    • Clinical remission

    • Stable treatment for at least 3 months

    Exclusion Criteria:

    • Colectomy

    • Neoplasia

    • Surgery in the last 6 months

    • Anticoagulant treatment

    • Major liver disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidade do Vale do Itajaí-UNIVALI / Santa Catarina Itajaí Santa Catarina Brazil
    2 Faculdade de Medicina de Botucatu -UNESP Botucatú SP Brazil 18607-621
    3 Clinical Hospital of São Paulo University São Paulo SP Brazil 05403-010

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    • Principal Investigator: Andre ZA Leite, MD, Clinical Hospital of São Paulo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT02445690
    Other Study ID Numbers:
    • USP
    First Posted:
    May 15, 2015
    Last Update Posted:
    May 12, 2016
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Crohn Disease
    Thrombosis

    Study Results

    No Results Posted as of May 12, 2016