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Thrombin Generation in Crohn's Disease

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ClinicalTrials.gov Identifier: NCT02445690
Recruitment Status : Unknown
Verified May 2015 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : May 15, 2015
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date May 12, 2015
First Posted Date May 15, 2015
Last Update Posted Date May 12, 2016
Study Start Date May 2015
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2015)
Correlation between thrombin generation and endoscopic activity [ Time Frame: At the moment of the inclusion ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 12, 2015)
Association of a high thrombin generation and development of deep vein thrombosis [ Time Frame: After 1 year of follow up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thrombin Generation in Crohn's Disease
Official Title Correlation Between Thrombin Generation and Endoscopic Activity in Crohn's Disease
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Retention:   Samples Without DNA
Description:
5ml of plasm
Sampling Method Probability Sample
Study Population Patients with established Crohn's disease with stable treatment and clinical remission
Condition
  • Crohn Disease
  • Blood Clot
  • Thrombosis
Intervention Not Provided
Study Groups/Cohorts
  • Clinical remission without inflammation
    Patients with Crohn's disease in clinical remission and no inflammation in the colonoscopy
  • Clinical remission with inflammation
    Patients with Crohn's disease in clinical remission and active inflammation in the colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 12, 2015)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT02445690
Other Study ID Numbers USP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Sao Paulo General Hospital
Study Sponsor University of Sao Paulo General Hospital
Collaborators Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Andre ZA Leite, MD Clinical Hospital of São Paulo University
PRS Account University of Sao Paulo General Hospital
Verification Date May 2015