UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter prospective cohort study to reveal the incidence and risk factors of venous thromboembolism in Japanese patients with IBD.
Title of the study (Brief title)	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	Mikihiro Fujiya
Organization	Asahikawa Medical University
Division name	Department of medicine, Division of gastroenterology and hematology/oncology
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	Katsuyoshi Ando
Organization	Asahikawa Medical University
Division name	Department of Community Medicine Management
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 04 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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