Thrombin Generation in Crohn's Disease

May 11, 2016 updated by: University of Sao Paulo General Hospital

Correlation Between Thrombin Generation and Endoscopic Activity in Crohn's Disease

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Botucatú, SP, Brazil, 18607-621
        • Active, not recruiting
        • Faculdade de Medicina de Botucatu -UNESP
      • São Paulo, SP, Brazil, 05403-010
        • Recruiting
        • Clinical Hospital of Sao Paulo University
        • Contact:
        • Principal Investigator:
          • André ZA Leite, MD
        • Sub-Investigator:
          • Adriana R Andrade, MD
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil
        • Withdrawn
        • Universidade do Vale do Itajaí-UNIVALI / Santa Catarina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with established Crohn's disease with stable treatment and clinical remission

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between thrombin generation and endoscopic activity
Time Frame: At the moment of the inclusion
At the moment of the inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Association of a high thrombin generation and development of deep vein thrombosis
Time Frame: After 1 year of follow up
After 1 year of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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