Thrombin Generation in Crohn's Disease

Study Overview
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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.

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.

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

Conditions
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Crohn Disease, Blood Clot, Thrombosis

Participation Criteria
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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 Exclusion Criteria: Colectomy Neoplasia Surgery in the last 6 months Anticoagulant treatment Major liver disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical remission without inflammation<br>Patients with Crohn's disease in clinical remission and no inflammation in the colonoscopy | |
| Clinical remission with inflammation<br>Patients with Crohn's disease in clinical remission and active inflammation in the colonoscopy | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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