Inflammatory Bowel Disease and Thromboembolic Events
Sponsor
Centro Hospitalar Tondela-Viseu (Other)
Overall Status
Completed
CT.gov ID
NCT05162339
Collaborator
Portuguese IBD Group (Other)
149
1
41.9
3.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
149 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inflammatory Bowel Disease and Thromboembolic Events
Actual Study Start Date
:
Nov 1, 2016
Actual Primary Completion Date
:
Apr 30, 2020
Actual Study Completion Date
:
Apr 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| IBD patients
|
Other: No intervention was made
No intervention was made
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro Hospitalar Tondela Viseu | Viseu | Portugal | 3504-509 |
Sponsors and Collaborators
- Centro Hospitalar Tondela-Viseu
- Portuguese IBD Group
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ana Carvalho,
Principal Investigator,
Centro Hospitalar Tondela-Viseu
ClinicalTrials.gov Identifier:
NCT05162339
Other Study ID Numbers:
- CHTV07/2020.1
First Posted:
Dec 17, 2021
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: