UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044098 |
|---|---|
| Receipt number | R000050358 |
| Scientific Title | Kobe Aneurysmal Subarachnoid Hemorrhage and Delayed Ischemic Neurological Deficit Registry 2 (KASHER2) |
| Date of disclosure of the study information | 2021/05/03 |
| Last modified on | 2021/05/03 12:21:53 |
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Basic information
Public title
Kobe Aneurysmal Subarachnoid Hemorrhage and Delayed Ischemic Neurological Deficit Registry 2
(KASHER2)
Acronym
Kobe Aneurysmal Subarachnoid Hemorrhage and Delayed Ischemic Neurological Deficit Registry 2
(KASHER2)
Scientific Title
Kobe Aneurysmal Subarachnoid Hemorrhage and Delayed Ischemic Neurological Deficit Registry 2
(KASHER2)
Scientific Title:Acronym
Kobe Aneurysmal Subarachnoid Hemorrhage and Delayed Ischemic Neurological Deficit Registry 2
(KASHER2)
Region
| Japan |
Condition
Condition
Intracranial aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate delayed ischemic neurological disorder due to aneurysmal subarachnoid hemorrhage in all primary stroke centers in the Kobe city.
Basic objectives2
Others
Basic objectives -Others
Observationalstudy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of cerebral infarction of delayed ischemic neurological disorder due to aneurysmal subarachnoid hemorrhage
Key secondary outcomes
1. Frequency of delayed ischemic neurological disorder due to aneurysmal subarachnoid hemorrhage
2. disabling stroke or death at 30days after admission or discharge
3. disabling stroke or death at 60days after admission
4. disabling stroke or death at 12months after admission
5. rebleeding of target aneurysm within 1 year
6. retreatment of target aneurysm within 1 year
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
1. subarachnoid hemorrage due to rupture of intracranial aneurysm
2. admitted to hospital within 14 days since last onset
Key exclusion criteria
No limitation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center General Hospital
Division name
Neurosurgery
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
n.sakai@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Sakai |
Organization
Kobe City Medical Center General Hospital
Division name
Neurosurgery
Zip code
650-0047
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
078-302-4321
Homepage URL
n.sakai@siren.ocn.ne.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Idorsia Pharmaceuticals Japan Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
Tel
078-302-4321
rinken@kcho.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
神戸市立医療センター中央市民病院（神戸市）、西神戸医療センター（神戸市）、神戸大学病院（神戸市）、神戸赤十字病院/災害医療センター（神戸市）、神鋼記念病院（神戸市）、吉田病院（神戸市）、甲南医療センター（神戸市）、恒生病院（神戸市）、神戸掖済会病院（神戸市）、新須磨病院（神戸市）、神戸医療センター（神戸市）、神戸市立医療センター西市民病院（神戸市）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2032 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We hope to secure adequet information to improve outcome of aneurysmal subarachnoid patients, as we conduct retrospective study about delayed neurological disorder due to aneurysmal subarachnoid hemorrhage at all primary stroke center in the Kobe city.
Management information
Registered date
| 2021 | Year | 05 | Month | 03 | Day |
Last modified on
| 2021 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050358
