Status:
UNKNOWN
Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Inflammatory Bowel Diseases
Thrombosis
Eligibility:
All Genders
18+ years
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 plate...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 15 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04896203
Start Date
November 18 2020
End Date
February 15 2022
Last Update
July 23 2021
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrd, Spain, 28046