UMIN-CTR Clinical Trial

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

Inflammatory Bowel Disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Asahikawa Medical University

Institute

Department

Personal name

Organization

Self-sustaining

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

12

Month

22

Day

Last modified on

2017

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034842