Clinical trial NCT02445690: Thrombin Generation in Crohn's Disease
Official title: Correlation Between Thrombin Generation and Endoscopic Activity in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Blood Clot
Thrombosis
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-05-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with established Crohn's disease with stable treatment and clinical remission

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.

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

Primary outcomes:
measure: Correlation between thrombin generation and endoscopic activity
timeFrame: At the moment of the inclusion
Secondary outcomes:
measure: Association of a high thrombin generation and development of deep vein thrombosis
timeFrame: After 1 year of follow up
Other outcomes:
Locations:
city: Itajaí
country: Brazil
facility: Universidade do Vale do Itajaí-UNIVALI / Santa Catarina
state: Santa Catarina
city: Botucatú
country: Brazil
facility: Faculdade de Medicina de Botucatu -UNESP
state: SP
city: São Paulo
country: Brazil
facility: Clinical Hospital of São Paulo University
state: SP
Study officials:
affiliation: Clinical Hospital of São Paulo University
name: Andre ZA Leite, MD
role: PRINCIPAL_INVESTIGATOR
References: