Crohn DiseaseNCT02445690
Thrombin Generation in Crohn's Disease
An observational study of Crohn Disease and Blood Clot, run by University of Sao Paulo General Hospital at 3 sites in Brazil.
Trial summary
One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission, with or without endoscopic activity will be included. Thrombin generation will be measured and correlated with the simplified endoscopic activity score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Blood Clot, Thrombosis
- How many people
- 150 participants
- Where
- 3 sitesBrazil
- Study dates
- May 2015to Apr 2017
- How long will I take part?
- 12 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 established Crohn's disease with stable treatment and clinical remission
Who may be able to join
- Established Crohn's disease diagnosis for at least 6 months
- Disease involvement of the terminal ileum and/or colon
- Clinical remission
- Stable treatment for at least 3 months
Who cannot join
- Colectomy
- Neoplasia
- Surgery in the last 6 months
- Anticoagulant treatment
- Major liver disease
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 1 recruiting
- Active, not recruiting
Faculdade de Medicina de Botucatu -UNESP
Botucatú, São Paulo, 18607-621
- Withdrawn
Universidade do Vale do Itajaí-UNIVALI / Santa Catarina
Itajaí, Santa Catarina
- Recruiting
Clinical Hospital of São Paulo University
São Paulo, São Paulo, 05403-010
Andre ZA Leite, MD, +551130617279, azaleite@gmail.com
André ZA Leite, MD
About this study
Official title: Correlation Between Thrombin Generation and Endoscopic Activity in Crohn's Disease
One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission, with or without endoscopic activity will be included. Thrombin generation will be measured and correlated with the simplified endoscopic activity score. The patients will be evaluated for development of deep vein thrombosis after one-year of follow-up.
Read the detailed description
One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission defined by the Crohn's Disease Activity Index below 150 and Harvey-Bradshaw Index below 5, with or without endoscopic activity defined by simplified endoscopic activity score for Crohn's disease (SES-CD) will be included in this study (75 patients with a complete mucosal healing defined by SES-CD below 3 and 75 with endoscopic activity defined by SES-CD above 6) in multiple centers specializing in the treatment of inflammatory bowel diseases in Brazil; Study data will be collected and managed using REDCap electronic data capture tools hosted at the Clinical Hospital of University of São Paulo. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies. All thrombin generation tests will be performed at the Clinical Hospital of University of São Paulo, São Paulo, SP through automatically calibrated Thrombogram (CAT- Calibrated Automated Thrombogram®, Maastricht, The Netherlands), with and without thrombomodulin. Those patients will be followed for at least one year after the colonoscopy with measurement of the D-dimer and clinical evaluation every 3 months to verify the developing of deep vein thrombosis.
- Conditions
- Crohn Disease, Blood Clot, Thrombosis
- Medical subject headings
- Crohn Disease, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical remission without inflammation | Patients with Crohn's disease in clinical remission and no inflammation in the colonoscopy | |
| Clinical remission with inflammation | Patients with Crohn's disease in clinical remission and active inflammation in the colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between thrombin generation and endoscopic activity
Measured: At the moment of the inclusion
Secondary outcomes (1)
Association of a high thrombin generation and development of deep vein thrombosis
Measured: After 1 year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- 150 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Andre ZA Leite, MD, Principal investigator, Clinical Hospital of São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445690
- Sponsor's protocol ID
- USP
- Status last verified
- May 2015
- First submitted
- 12 May 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Thrombin Generation and Endoscopic Activity in Crohn's Disease
- ClinicalTrials.gov ID
- NCT02445690
- Acronym / sponsor ID
- USP
- Conditions
- Crohn Disease, Blood Clot, Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 15 May 2015 (estimated)
- 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.
One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission, with or without endoscopic activity will be included. Thrombin generation will be measured and correlated with the simplified endoscopic activity score. The patients will be evaluated for development of deep vein thrombosis after one-year of follow-up.
Detailed description
One hundred and fifty patients with Crohn's disease involving the terminal ileum or the colon, in clinical remission defined by the Crohn's Disease Activity Index below 150 and Harvey-Bradshaw Index below 5, with or without endoscopic activity defined by simplified endoscopic activity score for Crohn's disease (SES-CD) will be included in this study (75 patients with a complete mucosal healing defined by SES-CD below 3 and 75 with endoscopic activity defined by SES-CD above 6) in multiple centers specializing in the treatment of inflammatory bowel diseases in Brazil; Study data will be collected and managed using REDCap electronic data capture tools hosted at the Clinical Hospital of University of São Paulo. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies. All thrombin generation tests will be performed at the Clinical Hospital of University of São Paulo, São Paulo, SP through automatically calibrated Thrombogram (CAT- Calibrated Automated Thrombogram®, Maastricht, The Netherlands), with and without thrombomodulin. Those patients will be followed for at least one year after the colonoscopy with measurement of the D-dimer and clinical evaluation every 3 months to verify the developing of deep vein thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical remission without inflammation | – | –Patients with Crohn's disease in clinical remission and no inflammation in the colonoscopy |
| Clinical remission with inflammation | – | –Patients with Crohn's disease in clinical remission and active inflammation in the colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with established Crohn's disease with stable treatment and clinical remission
Key inclusion criteria (4 listed)
- Established Crohn's disease diagnosis for at least 6 months
- Disease involvement of the terminal ileum and/or colon
- Clinical remission
- Stable treatment for at least 3 months
Key exclusion criteria (5 listed)
- Colectomy
- Neoplasia
- Surgery in the last 6 months
- Anticoagulant treatment
- Major liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between thrombin generation and endoscopic activity
Time frame: At the moment of the inclusion
1 secondary outcome
Association of a high thrombin generation and development of deep vein thrombosis
Time frame: After 1 year of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
Andre ZA Leite, MD principal investigator
Clinical Hospital of São Paulo University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Blood Clot, run by University of Sao Paulo General Hospital at 3 sites in Brazil.
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 5 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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 Andre ZA Leite, MD (+551130617279, azaleite@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between thrombin generation and endoscopic activity (time frame: At the moment of the inclusion). 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 12 May 2016.