Thrombin Generation in Crohn's Disease | NCT02445690

Studies
Thrombin Generation in Crohn's Disease

NCT02445690

Sponsor

University of Sao Paulo General Hospital

Status

Unknown status

Last Update Posted

May 12, 2016Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Crohn Disease
Blood Clot
Thrombosis

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Apr 2017Estimated

Completion Date

Apr 2017Estimated

First Submitted Date

May 12, 2015

First Submission Date that Met QC Criteria

May 12, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 12, 2016Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between thrombin generation and endoscopic activity		At the moment of the inclusion

Secondary Outcomes

Measure	Description	Time Frame
Association of a high thrombin generation and development of deep vein thrombosis		After 1 year of follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Colectomy
Neoplasia
Surgery in the last 6 months
Anticoagulant treatment
Major liver disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with established Crohn's disease with stable treatment and clinical remission

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andre ZA Leite, MD	Contact	+551130617279		azaleite@gmail.com

Overall Officials

Name	Affiliation	Role
Andre ZA Leite, MD	Clinical Hospital of São Paulo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade do Vale do Itajaí-UNIVALI / Santa Catarina	Withdrawn	Itajaí	Santa Catarina		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D013927	Thrombosis

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

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