Inflammatory Bowel Disease and Thromboembolic Events

Completed

• Conditions: Inflammatory Bowel Diseases; Thromboembolism; Coagulation Disorder
• Interventions: Other: No intervention was made

• Registration Number: NCT05162339
• Lead Sponsor: Centro Hospitalar Tondela-Viseu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2021-12
• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2021-12-04
• Last Update Submitted: 2021-12-04
• Study First Posted: 2021-12-17
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD patients	No intervention was made	-

Primary Outcome Measures

Name	Time	Method
Prevalence of thromboembolic events in IBD	36 months	To evaluate the coagulation parameters and the prevalence of thromboembolic events in IBD patients
Coagulation parameters variations in IBD	36 months	To investigate the correlation between coagulation parameters and disease phenotype and activity.

Trial Locations

Locations (1)

Centro Hospitalar Tondela Viseu; 🇵🇹 Viseu, Portugal