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NCT05162339 Clinical Trial

Inflammatory Bowel Disease and Thromboembolic Events

Inflammatory Bowel Diseases Clinical Trial

Official title:
Inflammatory Bowel Disease and Thromboembolic Events

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05162339
Other study ID # CHTV07/2020.1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2016
Est. completion date April 30, 2020

Study information
Verified date December 2021
Source Centro Hospitalar Tondela-Viseu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The main objective was to demonstrate the existence and importance of hypercoagulability in patients with IBD, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events.

Recruitment information / eligibility
Status Completed
Enrollment 149
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with 18 years of age or older, diagnosed with IBD, followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu, between November 2016 and April 2017. Exclusion Criteria: - Individuals with other risk factors for TE (severe hepatic or renal failure, valvular heart disease, atrial fibrillation, heart failure or cardiomyopathy, pregnancy, and oral anticoagulants or heparin at the baseline).

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention was made
No intervention was made

Locations
Country Name City State
Portugal Centro Hospitalar Tondela Viseu Viseu

Sponsors (2)
Lead Sponsor Collaborator
Centro Hospitalar Tondela-Viseu Portuguese IBD Group

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of thromboembolic events in IBD To evaluate the coagulation parameters and the prevalence of thromboembolic events in IBD patients 36 months
Primary Coagulation parameters variations in IBD To investigate the correlation between coagulation parameters and disease phenotype and activity. 36 months
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