NCT04896203

Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Descriptive study, in which the haemostatic profile of ambulatory patients with IBD will be analyzed by means of ROTEM and other techniques, such as the thrombin generation test and the study of platelet function by flow cytometry.

Detailed description

Descriptive study, in which the haemostatic profile of ambulatory patients with IBD will be analyzed by rotational thromboelastometry (ROTEM) and other techniques, such as thrombin generation test and platelet function study by flow cytometry. The results of these measurements will be subsequently compared between the different IBD patient groups, stratified by activity and other risk factors, as well as with healthy controls, in order to define in which of these situations a significant prothrombotic risk exists, and which part of the coagulation cascade conditions that risk. After this, we will describe the incidence and prevalence of thromboembolic events in the follow-up of these patient groups. Finally, an attempt will be made to determine, according to the results of the study if any of the situations outside the classic recommendations would be subsidiary to receive chemoprophylaxis for the thromboembolic events. The aim of this study is to determine the possible state of hypercoagulability of ambulatory patients with Inflammatory Bowel Disease, stratified according to the characteristics of their disease, by using ROTEM as well as the thrombin generation test. Platelet function will also be evaluated by flow cytometry.

Conditions

• Inflammatory Bowel Diseases
• Thrombosis
• Blood Coagulation Disorder

Interventions

Type	Name	Description
PROCEDURE	rotational thromboelastometry	Viscoelastometric method useful to study the kinetics of clot formation and fibrinolysis, providing a global information of both the cellular component and the pro and anticoagulant proteins, as well as the interactions between both components.

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-12-15
• Completion: 2022-02-15
• First posted: 2021-05-21
• Last updated: 2021-07-23

Locations

1 site across 1 country: Spain