UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034242 |
|---|---|
| Receipt number | R000037884 |
| Scientific Title | Study of the therapy, age, complication and outcome for ruptured and unruptured cerebral aneurysm using DPC |
| Date of disclosure of the study information | 2018/09/22 |
| Last modified on | 2023/09/26 16:35:19 |
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Basic information
Public title
Study of the therapy, age, complication and outcome for ruptured and unruptured cerebral aneurysm using DPC
Acronym
Study of the cerebral aneurysm using DPC
Scientific Title
Study of the therapy, age, complication and outcome for ruptured and unruptured cerebral aneurysm using DPC
Scientific Title:Acronym
Study of the cerebral aneurysm using DPC
Region
| Japan |
Condition
Condition
the cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the difference in outcome and complication according to the therapy and age in the cerebral aneurysm
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Rankin scale at discharge
Barthel index at discharge
Key secondary outcomes
complication at discharge
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
aneurysmal subarachnoid hemorrhage
unruptured cerebral aneurysm
Key exclusion criteria
non-aneurysmal subarachnoid hemorrhage
Target sample size
40000
Research contact person
Name of lead principal investigator
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Neurosurgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5226
fikawa-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Neurosurgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5226
Homepage URL
fikawa-nsu@umin.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science, Grant-in-Aid for Scientific Research (C) 17K1082
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Graduate School of Biomedical and Health Sciences Hiroshima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Biomedical and Health Sciences Hiroshima University
Address
1-2-3 Kasumi, Minami-ku
Tel
082-257-5907
kasumi-kenkyu@office.hiroshima-u.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
広島大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
partially published in this study
Publication of results
Partially published
Result
URL related to results and publications
partially published in this study
Number of participants that the trial has enrolled
30000
Results
Good results were achieved by Japan.
Results date posted
| 2022 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Facilities participating in DPC
Participant flow
Facilities participating in DPC
Adverse events
None
Outcome measures
modified Rankin Scale at discharge
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Under analysis and before open
Management information
Registered date
| 2018 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037884
