UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030524
Receipt number 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 15:51:40

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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 or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



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

Value
https://center6.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