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临床试验/NCT02445690
NCT02445690Unknown不适用

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

University of Sao Paulo General Hospital3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
3
主要终点
Correlation between thrombin generation and endoscopic activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Colectomy
  • Neoplasia
  • Surgery in the last 6 months
  • Anticoagulant treatment
  • Major liver disease

结局指标

主要结局

Correlation between thrombin generation and endoscopic activity

时间窗: At the moment of the inclusion

次要结局

  • Association of a high thrombin generation and development of deep vein thrombosis(After 1 year of follow up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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