Thrombin Generation in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02445690
• Other study ID #: USP
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2015
• Last updated: May 11, 2016
• Start date: May 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2015
• Source: University of Sao Paulo General Hospital
• Contact: Andre ZA Leite, MD
• Phone: +551130617279
• Email: azaleite[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Clot
• Crohn Disease
• Thrombosis

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Botucatu -UNESP	Botucatú	SP
Brazil	Universidade do Vale do Itajaí-UNIVALI / Santa Catarina	Itajaí	Santa Catarina
Brazil	Clinical Hospital of São Paulo University	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between thrombin generation and endoscopic activity		At the moment of the inclusion	No
Secondary	Association of a high thrombin generation and development of deep vein thrombosis		After 1 year of follow up	No