UMIN-CTR Clinical Trial

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