Inflammatory Bowel Disease and Thromboembolic Events

NCT05162339 | Completed

• 1 other identifier: CHTV07/2020.1
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Thromboembolism; Coagulation Disorder

Outcome Measures

Primary Outcomes (2)

• Prevalence of thromboembolic events in IBD

  To evaluate the coagulation parameters and the prevalence of thromboembolic events in IBD patients

  36 months

• Coagulation parameters variations in IBD

  To investigate the correlation between coagulation parameters and disease phenotype and activity.

  36 months

Study Arms (1)

IBD patients

Other: No intervention was made

Interventions

No intervention was made OTHER

No intervention was made

IBD patients

Eligibility Criteria

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

Study Population

Patients with 18 years of age or older, diagnosed with IBD (ECCO criteria), and followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centro Hospitalar Tondela-Viseu: lead
• Portuguese IBD Group: collaborator

Study Sites (1)

Centro Hospitalar Tondela Viseu

Viseu, 3504-509, Portugal

Location

Related Publications (1)

• Carvalho AC, Pinho J, Cancela E, Vieira HM, Silva A, Ministro P. Inflammatory bowel disease and thromboembolic events: a c'lot to learn. Therap Adv Gastroenterol. 2022 May 25;15:17562848221100626. doi: 10.1177/17562848221100626. eCollection 2022.

  PMID: 35651649 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Thromboembolism; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 17, 2021
• Study Start: November 1, 2016
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

PT (1)