UMIN-CTR Clinical Trial

Basic information
Public title	A nation-wide surveillance about the incidences and risk factors of severe and fatal thromboembolism in inflammatory bowel disease (IBD) patients in Japan.
Acronym	A nation-wide surveillance about severe and fatal thromboembolism in IBD in Japan.
Scientific Title	A nation-wide surveillance about the incidences and risk factors of severe and fatal thromboembolism in inflammatory bowel disease (IBD) patients in Japan.
Scientific Title:Acronym	A nation-wide surveillance about severe and fatal thromboembolism in IBD in Japan.
Region	Japan

Condition
Condition	Inflammatory bowel disease (Ulcerative colitis and Crohn's disease)
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To survey the incidence of thromboembolism and risk factors for leading to severe condition and death in IBD
Basic objectives2	Others
Basic objectives -Others	The incidence and risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidences of arterial and venous thromboembolism progressing to severe condition and death in IBD patients.
Key secondary outcomes	1) The incidence of arterial and venous thromboembolism in patients with IBD 2) The risk factors of arterial and venous thromboembolism progressing to severe condition and death in IBD patients 3) The incidences of severe and fatal thromboembolism by location of the thromboembolic lesions in IBD patients 4) The incidences of antithrombotic therapy and its hemorrhagic complications in IBD patients 5) Days from the initiation of thromboembolism to the progression of severe condition or death in IBD patients.

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	The patients who were diagnosed as IBD and examined in participating institutes from January 2008 to December 2017.
Key exclusion criteria	1) The patients who declined participation to this study. 2) The patients who were judged ineligible for participating this study by the principal investigator.
Target sample size	35000

Research contact person
Name of lead principal investigator	1st name Mikihiro Middle name Last name Fujiya
Organization	Asahikawa Medical University
Division name	Gastroenterology and Endoscopy, Division of Metabolism and Biosystemic Science, Gastroenterology, and Hematology/Oncology, Department of Medicine
Zip code	078-8510
Address	2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL	0166682462
Email	fjym@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Katsuyoshi Middle name Last name Ando
Organization	Asahikawa Medical University Hospital
Division name	Department of Medicine (Metabolism, immunology, Gastroenterology and Hematology)
Zip code	078-8510
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	Asahikawa Medical University
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	Asahikawa Medical University ethics committee
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
Tel	0166-68-2462
Email	rs-kk.g@asahikawa-med.ac.jp

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	2020 Year 12 Month 07 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	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 14 Day
Date of IRB	2018 Year 11 Month 14 Day
Anticipated trial start date	2018 Year 11 Month 14 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The incidences of arterial and venous thromboembolism progressing to severe condition and death in IBD patients. The risk factors of arterial and venous thromboembolism progressing to severe condition and death in IBD patients The incidences of severe and fatal thromboembolism by location of the thromboembolic lesions in IBD patients

Management information
Registered date	2020 Year 12 Month 05 Day
Last modified on	2020 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048681