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

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 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

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

Value
https://center6.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