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Thrombin Generation in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease
Crohn Disease Blood Clot Thrombosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Correlation Between Thrombin Generation and Endoscopic Activity in Crohn's Disease
Study Start Date : May 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Thrombin

Group/Cohort
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



Primary Outcome Measures :
  1. Correlation between thrombin generation and endoscopic activity [ Time Frame: At the moment of the inclusion ]

Secondary Outcome Measures :
  1. Association of a high thrombin generation and development of deep vein thrombosis [ Time Frame: After 1 year of follow up ]

Biospecimen Retention:   Samples Without DNA
5ml of plasm


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with established Crohn's disease with stable treatment and clinical remission
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445690


Contacts
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Contact: Andre ZA Leite, MD +551130617279 azaleite@gmail.com

Locations
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Brazil
Universidade do Vale do Itajaí-UNIVALI / Santa Catarina Withdrawn
Itajaí, Santa Catarina, Brazil
Faculdade de Medicina de Botucatu -UNESP Active, not recruiting
Botucatú, SP, Brazil, 18607-621
Clinical Hospital of São Paulo University Recruiting
São Paulo, SP, Brazil, 05403-010
Contact: Andre ZA Leite, MD    +551130617279    azaleite@gmail.com   
Principal Investigator: André ZA Leite, MD         
Sub-Investigator: Adriana R Andrade, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Andre ZA Leite, MD Clinical Hospital of São Paulo University
Additional Information:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02445690    
Other Study ID Numbers: USP
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2015
Additional relevant MeSH terms:
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Crohn Disease
Thrombosis
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases