UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051115 |
|---|---|
| Receipt number | R000058298 |
| Scientific Title | Impact of aneurysmal size and treatment modalities on functional outcomes of ruptured large/giant intracranial aneurysms from multicenter database |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/05/21 10:21:28 |
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Basic information
Public title
Study of functional outcomes of ruptured large/giant intracranial aneurysms from multicenter database
Acronym
Outcomes of uptured large/giant intracranial aneurysms
Scientific Title
Impact of aneurysmal size and treatment modalities on functional outcomes of ruptured large/giant intracranial aneurysms from multicenter database
Scientific Title:Acronym
Impact of aneurysmal size and treatment modalities on functional outcomes of ruptured large/giant intracranial aneurysms
Region
| Japan |
Condition
Condition
ruptured cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate risk factors of functional outcomes of ruptured large/giant cerebral aneurysms
Basic objectives2
Others
Basic objectives -Others
Investigate impact of aneurysmal size and treatment modality on functional outcomes of ruptured large/giant cerebral aneurysms
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional outcomes at discharge
Key secondary outcomes
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
A patient who underwent treatment for their ruptured cerebral aneurysm, the size of which was no less than 10 mm
Key exclusion criteria
A patient who underwent treatment after 72 hours of onset
Target sample size
416
Research contact person
Name of lead principal investigator
| 1st name | HITOSHI |
| Middle name | |
| Last name | FUKUDA |
Organization
Kochi Medical School Hospital
Division name
Department of Neurosurgery
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2397
fukudaharpseal@gmail.com
Public contact
Name of contact person
| 1st name | HITOSHI |
| Middle name | |
| Last name | FUKUDA |
Organization
Kochi Medical School Hospital
Division name
Department of Neurosurgery
Zip code
783-8505
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2397
Homepage URL
fukudaharpseal@gmail.com
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
The other
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
Kochi University Hospital, Clinical Research Center
Address
185-1, Kohasu, Oko-cho, Nankoku, Kochi, Japan
Tel
088-880-2140
is21@kochi-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 01 | 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
416
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | 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
Association of aneurysmal size, treatment modalities, and their interactions with functional outcomes is analyzed.
Management information
Registered date
| 2023 | Year | 05 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058298
