Clinical trial NCT04896203: Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease
Official title: Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Thrombosis
Blood Coagulation Disorder
Keywords: Blood Coagulation
Blood CoagulationTests
Thrombelastography
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are being followed in the Inflammatory Bowel Disease unit of the Hospital Universitario La Paz.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Platelet Function
timeFrame: Baseline
measure: Protein expression on Platelets Surface
timeFrame: Baseline
Secondary outcomes:
measure: Thromboembolic Events
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Madrd
Study officials:
affiliation: Hospital Universitario La Paz
name: José Luis Rueda García
role: PRINCIPAL_INVESTIGATOR
References: