NCT04896203

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

November 24, 2020

Last Update Submit

July 22, 2021

Conditions

Inflammatory Bowel DiseasesThrombosisBlood Coagulation Disorder

Keywords

Blood CoagulationBlood CoagulationTestsThrombelastography

Outcome Measures

Primary Outcomes (2)

  • Platelet Function

    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

    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 Outcomes (1)

  • Thromboembolic Events

    Baseline

Study Arms (2)

Group 1

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

Procedure: rotational thromboelastometry

Group 2

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

Procedure: rotational thromboelastometry

Interventions

rotational thromboelastometryPROCEDURE

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 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrd, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesThrombosisBlood Coagulation Disorders

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • José Luis Rueda García

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Luis Rueda García

CONTACT

+34912071350ruedagarcia.joseluis@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2020

First Posted

May 21, 2021

Study Start

November 18, 2020

Primary Completion

December 15, 2021

Study Completion

February 15, 2022

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

ES(1)