UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049641 |
|---|---|
| Receipt number | R000056529 |
| Scientific Title | Association between aspirin dose and outcomes in patients with acute Kawasaki disease |
| Date of disclosure of the study information | 2022/11/29 |
| Last modified on | 2022/11/29 15:40:51 |
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Basic information
Public title
Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Acronym
Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Scientific Title
Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Scientific Title:Acronym
Association between aspirin dose and outcomes in patients with acute Kawasaki disease
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a Japanese national inpatient database, this study aimed to identify the appropriate dose of aspirin to be prescribed to patients with acute Kawasaki disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the occurrence of CAAs upon discharge. CAAs were identified with a recorded diagnosis of CAAs (ICD-10 code: I25.4) and/or text data of CAAs in the Japanese language.
Key secondary outcomes
The secondary outcomes were IVIG resistance, length of stay, medical costs, and adverse events.
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
| 3 | months-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient treated by IVIG
Key exclusion criteria
Patient doesn't treated by IVIG
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Department of pediatrics
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
+819025786815
takanori-s@axel.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health Universty
Division name
Department of pediatrics
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
+819025786815
Homepage URL
takanori-s@axel.ocn.ne.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo, Clinical Research Review Board
Address
Office for Human Research Studies Graduate School of Medicine and Faculty of Medicine, The University of Tokyo Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
gha10771@gmail.com
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
| 2022 | Year | 11 | Month | 29 | 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
10000
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2022 | Year | 11 | Month | 29 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056529
