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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044098
Receipt No. 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

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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
Email 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
Email n.sakai@siren.ocn.ne.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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