Inflammatory Bowel DiseasesEDGARNCT04896203
Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Thrombosis, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Thrombosis, Blood Coagulation Disorder
- What is being tested?
- rotational thromboelastometry
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 18 Nov 2020to 15 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are being followed in the Inflammatory Bowel Disease unit of the Hospital Universitario La Paz.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrd, 28046
Maria Dolores Martin Arranz, PhD, +34912071350, mmartinarranz@salud.madrid.org
About this study
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.
Read the 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.
- Being tested
- rotational thromboelastometry
- Keywords
- Blood Coagulation, Blood CoagulationTests, Thrombelastography
- Medical subject headings
- Inflammatory Bowel Diseases, Thrombosis, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotational thromboelastometryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Ulcerative Colitis or Crohn's Disease patients, in remission according to inclusion criteria Receives: Procedure: rotational thromboelastometry | |
| Group 2 | Ulcerative Colitis or Crohn's Disease patients, with activity defined by the inclusion criteria Receives: Procedure: rotational thromboelastometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline
Secondary outcomes (1)
Thromboembolic Events
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start18 Nov 2020
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
- Investigators
- José Luis Rueda García, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896203
- Sponsor's protocol ID
- PI-4182
- Acronym
- EDGAR
- Status last verified
- Jul 2021
- First submitted
- 24 Nov 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercoagulability Study Using Haemostatic Techniques in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04896203
- Acronym / sponsor ID
- EDGAR / PI-4182
- Keywords
- Blood Coagulation, Blood CoagulationTests, Thrombelastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: rotational thromboelastometryUlcerative Colitis or Crohn's Disease patients, in remission according to inclusion criteria |
| Group 2 | – | Procedure: rotational thromboelastometryUlcerative Colitis or Crohn's Disease patients, with activity defined by the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are being followed in the Inflammatory Bowel Disease unit of the Hospital Universitario La Paz.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rotational thromboelastometryViscoelastometric 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. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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.
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
1 secondary outcome
Thromboembolic Events
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luis Rueda García principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Thrombosis, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Luis Rueda García (+34912071350, ruedagarcia.joseluis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Function (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.