Inflammatory Bowel DiseasesNCT05162339
Inflammatory Bowel Disease and Thromboembolic Events
An observational study of Inflammatory Bowel Diseases and Thromboembolism, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
Trial summary
The main objective was to demonstrate the existence and importance of hypercoagulability in patients with IBD, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Thromboembolism, Coagulation Disorder
- How many people
- 149 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Nov 2016to 30 Apr 2020
- How long will I take part?
- 36 Months
- 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 with 18 years of age or older, diagnosed with IBD (ECCO criteria), and followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu
Who may be able to join
- Patients with 18 years of age or older, diagnosed with IBD, followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu, between November 2016 and April 2017.
Who cannot join
- Individuals with other risk factors for TE (severe hepatic or renal failure, valvular heart disease, atrial fibrillation, heart failure or cardiomyopathy, pregnancy, and oral anticoagulants or heparin at the baseline).
Trial locations and contacts
1 site in 1 country.
About this study
The main objective was to demonstrate the existence and importance of hypercoagulability in patients with IBD, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events.
- Being tested
- No intervention was made
- Medical subject headings
- Inflammatory Bowel Diseases, Thromboembolism, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was madeOther
No intervention was made
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Not described Receives: Other: No intervention was made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of thromboembolic events in IBD
To evaluate the coagulation parameters and the prevalence of thromboembolic events in IBD patients
Measured: 36 months
Coagulation parameters variations in IBD
To investigate the correlation between coagulation parameters and disease phenotype and activity.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start1 Nov 2016
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 149 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Tondela-Viseu
- Sponsor type
- University, hospital or other
- Collaborators
- Portuguese IBD Group
- Responsible party
- Principal investigator, Ana Carvalho, Centro Hospitalar Tondela-Viseu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162339
- Sponsor's protocol ID
- CHTV07/2020.1
- Status last verified
- Dec 2021
- First submitted
- 4 Dec 2021
- Last updated
- 17 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carvalho AC, Pinho J, Cancela E, Vieira HM, Silva A, Ministro P. Inflammatory bowel disease and thromboembolic events: a c'lot to learn. Ther Adv Gastroenterol. 2022 May 25;15:17562848221100626. doi: 10.1177/17562848221100626. eCollection 2022.
PubMed 35651649
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Bowel Disease and Thromboembolic Events
- ClinicalTrials.gov ID
- NCT05162339
- Acronym / sponsor ID
- CHTV07/2020.1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Centro Hospitalar Tondela-ViseuUniversity, hospital or other
- Collaborators
- Portuguese IBD Group
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 17 Dec 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.
The main objective was to demonstrate the existence and importance of hypercoagulability in patients with IBD, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Other: No intervention was made |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 18 years of age or older, diagnosed with IBD (ECCO criteria), and followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu
Key inclusion criteria (1 listed)
- Patients with 18 years of age or older, diagnosed with IBD, followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu, between November 2016 and April 2017.
Key exclusion criteria (1 listed)
- Individuals with other risk factors for TE (severe hepatic or renal failure, valvular heart disease, atrial fibrillation, heart failure or cardiomyopathy, pregnancy, and oral anticoagulants or heparin at the baseline).
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 |
|---|---|---|
| No intervention was madeNo intervention was made | Other | IBD patients |
Primary outcome
Prevalence of thromboembolic events in IBD
Time frame: 36 months
To evaluate the coagulation parameters and the prevalence of thromboembolic events in IBD patients
Coagulation parameters variations in IBD
Time frame: 36 months
To investigate the correlation between coagulation parameters and disease phenotype and activity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Derived from this study: PubMed 35651649Carvalho AC, Pinho J, Cancela E, Vieira HM, Silva A, Ministro P. Inflammatory bowel disease and thromboembolic events: a c'lot to learn. Ther Adv Gastroenterol. 2022 May 25;15:17562848221100626. doi: 10.1177/17562848221100626. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thromboembolism, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Dec 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of thromboembolic events in IBD (time frame: 36 months). 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?
On the ClinicalTrials.gov record for NCT05162339, which also lists 1 linked publication.
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 17 Dec 2021.