UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042665 |
|---|---|
| Receipt number | R000048681 |
| 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. |
| Date of disclosure of the study information | 2020/12/07 |
| Last modified on | 2020/12/05 21:42:09 |
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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
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
k-ando@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048681
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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