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

Sponsor

Hospital Universitario La Paz (Other)

Overall Status

Recruiting

CT.gov ID

NCT04896203

Collaborator

(none)

Enrollment

Location

14.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Thrombosis Blood Coagulation Disorder	Procedure: rotational thromboelastometry

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease

Actual Study Start Date :

Nov 18, 2020

Anticipated Primary Completion Date :

Dec 15, 2021

Anticipated Study Completion Date :

Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Ulcerative Colitis or Crohn's Disease patients, in remission according to inclusion criteria	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.
Group 2 Ulcerative Colitis or Crohn's Disease patients, with activity defined by the inclusion criteria	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.

Arm

Intervention/Treatment

Group 1

Ulcerative Colitis or Crohn's Disease patients, in remission according to inclusion criteria

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.

Group 2

Ulcerative Colitis or Crohn's Disease patients, with activity defined by the inclusion criteria

Procedure: rotational thromboelastometry

Outcome Measures

Primary Outcome Measures

Platelet Function [Baseline]
Platelet activation will be evaluated by flow cytometry through analysis of fibrinogen (Fg) receptor activation and by exposure of P-selectin and CD63 on the surface of the platelets, in the basal state and after activation with thrombin receptor agonists.
Protein expression on Platelets Surface [Baseline]
Calibrated Automated Thrombogram (CAT) will be used to measure thrombin generation. CAT is a fluorimetric method that quantifies the amount of thrombin generated in a plasma sample after activation of the coagulation

Secondary Outcome Measures

Thromboembolic Events [Baseline]
Thromboembolic events are one of the leading causes of mortality in Inflammatory Bowel Disease, and can occur in any of its subtypes. The most frequent are deep vein thrombosis of lower limbs and pulmonary thromboembolism.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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