Thrombin Generation in Crohn's Disease

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Blood Clot
Thrombosis
Crohn Disease

Study type

Observational

Funder types

Other

Identifiers

NCT02445690
USP

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Clinical remission without inflammation
Description:
Patients with Crohn's disease in clinical remission and no inflammation in the colonoscopy
Clinical remission with inflammation
Description:
Patients with Crohn's disease in clinical remission and active inflammation in the colonoscopy

Trial contacts and locations

0

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Central trial contact

Andre ZA Leite, MD

Data sourced from clinicaltrials.gov

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