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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030524
Receipt No. R000034842
Scientific Title Multicenter prospective cohort study to reveal the incidence and risk factors of venous thromboembolism in Japanese patients with IBD.
Date of disclosure of the study information 2017/12/25
Last modified on 2017/12/22

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Basic information
Public title Multicenter prospective cohort study to reveal the incidence and risk factors of venous thromboembolism in Japanese patients with IBD.
Acronym Multicenter prospective cohort study for venous thromboembolism in Japanese IBD patients.
Scientific Title Multicenter prospective cohort study to reveal the incidence and risk factors of venous thromboembolism in Japanese patients with IBD.
Scientific Title:Acronym Multicenter prospective cohort study for venous thromboembolism in Japanese IBD patients.
Region
Japan

Condition
Condition Inflammatory Bowel Disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the incidence and risk factors of venous thromboembolism in Japanese patients with IBD.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of venous thromboembolism in inpatients with IBD.
Key secondary outcomes 1. Risk of onset for VTE in IBD compared with that in other digestive diseases
2. The site of VTE development, treatment for VTE, outcome of VTE
3. The risk factors of VTE in IBD

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients of any age (male or female)
2. Patients who agree to participate this study after receiving an explanation and providing consent forms
If target patients are under 20 years of age, the legal representative (parents and so on) needs to agree with their participation in this study after receiving an explanation and providing consent forms.
3. Patients who admit to a hospital.
4. Patients who admit for the reason of developing VTE can be registered in this study.
5. Patients with pouchitis after colectomy for UC can be registered in this study.
6. Patients who have either benign or malignant disorder in the group with other digestive disease can be registered.
Key exclusion criteria 1. IBD patients to whom steroids, immunomodulators and biologics need to be administrated for the treatments of disease other than IBD and IBD-related manifestation.
2. Patients who need to receive intensive care for severe complications such as cardiovascular disorder (heart failure, acute coronary syndrome and so on) and pulmonary disorder (respiratory failure, severe pneumonia, bronchial asthma intussusception and so on).
3. Patients with restrictions on their activities, who have malignant tumor with distant metastasis, severe organ failure or are in a terminal state.
4. Patients who are not confirmed to have a diagnosis of IBD, such as IBD unclassified.
5. Patients who do not agree to participate in this study regardless of having received an explanation and consent forms.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikihiro Fujiya
Organization Asahikawa Medical University
Division name Department of medicine, Division of gastroenterology and hematology/oncology
Zip code
Address 2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2462
Email fjym@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyoshi Ando
Organization Asahikawa Medical University
Division name Department of Community Medicine Management
Zip code
Address 2-1-1-1-, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2462
Homepage URL
Email k-ando@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Self-sustaining
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The presence of VTE in inpatients with IBD and other digestive diseases is surveied with contrast enhanced computed tomography or ultrasonography at two points (on admission, and one to two weeks later).The incidence of VTE in patients with IBD is investigated, which is compared with that in patients with other digestive diseases. The risk factors of VTE with IBD are analyzed with charactaristics and laboratory data.

Management information
Registered date
2017 Year 12 Month 22 Day
Last modified on
2017 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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