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

July 22, 2021 updated by: María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrd
      • Madrid, Madrd, Spain, 28046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are being followed in the Inflammatory Bowel Disease unit of the Hospital Universitario La Paz.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Function
Time Frame: 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.
Baseline
Protein expression on Platelets Surface
Time Frame: 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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboembolic Events
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Investigators

  • Principal Investigator: José Luis Rueda García, Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Anticipated)

December 15, 2021

Study Completion (Anticipated)

February 15, 2022

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-4182

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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