Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-18

Study Completion Date

2022-02-15

Brief Summary

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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.

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Detailed Description

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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

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Inflammatory Bowel Diseases Thrombosis Blood Coagulation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

rotational thromboelastometry

Intervention Type PROCEDURE

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

rotational thromboelastometry

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No