Thrombin Generation in Crohn's Disease

• Conditions: Thrombosis; Blood Clot; Crohn Disease

• Registration Number: NCT02445690
• Lead Sponsor: University of Sao Paulo General Hospital

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.

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 Timeline

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between thrombin generation and endoscopic activity	At the moment of the inclusion

Secondary Outcome Measures

Name	Time	Method
Association of a high thrombin generation and development of deep vein thrombosis	After 1 year of follow up

Trial Locations

Locations (3)

Universidade do Vale do Itajaí-UNIVALI / Santa Catarina; 🇧🇷 Itajaí, Santa Catarina, Brazil

Faculdade de Medicina de Botucatu -UNESP; 🇧🇷 Botucatú, SP, Brazil

Clinical Hospital of São Paulo University; 🇧🇷 São Paulo, SP, Brazil