Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease (EDGAR)

Madrid Health Service

Status

Unknown

Conditions

Thrombosis

Inflammatory Bowel Diseases

Blood Coagulation Disorder

Treatments

Procedure: rotational thromboelastometry

Study type

Observational

Funder types

Other

Identifiers

NCT04896203

PI-4182

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients over 18 years old
Patients diagnosed with UC according to ECCO criteria, in ambulatory follow-up in the IBD unit, stratified in remission and mild or moderate ambulatory management activity, determined by clinical (Simple Clinical Colitis Activity Index: SCCAI), biological (fecal calprotectin: CF), and/or endoscopic (Mayo Index) criteria: Remission: defined as a SCCAI < 2 and/or CF < 150 and/or May 0 index Activity: defined as an SCCAI >2, and/or CF > 150, and/or May Index >= 1 and <3.
Patients diagnosed with CD according to ECCO criteria, in ambulatory follow-up in the IBD unit, stratified according to remission and mild or moderate ambulatory management activity, determined by clinical criteria (Harvey-Bradshaw index: HBI), biological criteria (CF) and/or endoscopic criteria (Simple Endoscopic Score-CD: SES-CD):

Remission: HBI < 5, and/or CF < 150, and/or SES CD < 3. Activity: HBI >=6 and <16, and/or CF > 150, and/or SES-CD >=3 (>4 if isolated ileal affectation) and <=15.

Exclusion criteria

Patients with a previous history of venous or arterial thromboembolism
Patients with recent hospitalization or surgery in the last 3 months.
Women who are pregnant, undergoing treatment with oral contraceptives or who have received oral contraceptives in the last 3 months.
Patients undergoing anticoagulation and/or active antiaggregation treatment
Patients with severe activity criteria
Patients with other concomitant conditions that favor thrombosis events