Thrombin Generation in Crohn's Disease

NCT02445690 | Unknown DMC

• 1 other identifier: USP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Crohn Disease; Blood Clot; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Correlation between thrombin generation and endoscopic activity

  At the moment of the inclusion

Secondary Outcomes (1)

• Association of a high thrombin generation and development of deep vein thrombosis

  After 1 year of follow up

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with established Crohn's disease with stable treatment and clinical remission

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (3)

Universidade do Vale do Itajaí-UNIVALI / Santa Catarina

Itajaí, Santa Catarina, Brazil

WITHDRAWN

Faculdade de Medicina de Botucatu -UNESP

Botucatú, São Paulo, 18607-621, Brazil

ACTIVE NOT RECRUITING

Clinical Hospital of São Paulo University

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

5ml of plasm

MeSH Terms

Conditions

Crohn Disease; Thrombosis

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andre ZA Leite, MD

  Clinical Hospital of São Paulo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre ZA Leite, MD

CONTACT

+551130617279; azaleite@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 15, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 12, 2016

Record last verified: 2015-05

Locations

BR (3)