Thrombin Generation in Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn Disease Blood Clot Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinical remission without inflammation

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

No interventions assigned to this group

Clinical remission with inflammation

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

No interventions assigned to this group

Eligibility Criteria

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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