UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034242
Receipt number R000037884
Scientific Title Study of the therapy, age, complication and outcome for ruptured and unruptured cerebral aneurysm using DPC
Date of disclosure of the study information 2018/09/22
Last modified on 2023/09/26 16:35:19

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Basic information

Public title

Study of the therapy, age, complication and outcome for ruptured and unruptured cerebral aneurysm using DPC

Acronym

Study of the cerebral aneurysm using DPC

Scientific Title

Study of the therapy, age, complication and outcome for ruptured and unruptured cerebral aneurysm using DPC

Scientific Title:Acronym

Study of the cerebral aneurysm using DPC

Region

Japan


Condition

Condition

the cerebral aneurysm

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to evaluate the difference in outcome and complication according to the therapy and age in the cerebral aneurysm

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

modified Rankin scale at discharge
Barthel index at discharge

Key secondary outcomes

complication at discharge


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

110 years-old >=

Gender

Male and Female

Key inclusion criteria

aneurysmal subarachnoid hemorrhage
unruptured cerebral aneurysm

Key exclusion criteria

non-aneurysmal subarachnoid hemorrhage

Target sample size

40000


Research contact person

Name of lead principal investigator

1st name Fusao
Middle name
Last name Ikawa

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Neurosurgery

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

082-257-5226

Email

fikawa-nsu@umin.ac.jp


Public contact

Name of contact person

1st name Fusao
Middle name
Last name Ikawa

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Neurosurgery

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

082-257-5226

Homepage URL


Email

fikawa-nsu@umin.ac.jp


Sponsor or person

Institute

Ministry of Education, Culture, Sports, Science and Technology

Institute

Department

Personal name



Funding Source

Organization

the Japan Society for the Promotion of Science, Grant-in-Aid for Scientific Research (C) 17K1082

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Graduate School of Biomedical and Health Sciences Hiroshima University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Biomedical and Health Sciences Hiroshima University

Address

1-2-3 Kasumi, Minami-ku

Tel

082-257-5907

Email

kasumi-kenkyu@office.hiroshima-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

広島大学


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 22 Day


Related information

URL releasing protocol

partially published in this study

Publication of results

Partially published


Result

URL related to results and publications

partially published in this study

Number of participants that the trial has enrolled

30000

Results

Good results were achieved by Japan.

Results date posted

2022 Year 09 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Facilities participating in DPC

Participant flow

Facilities participating in DPC

Adverse events

None

Outcome measures

modified Rankin Scale at discharge

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Suspended

Date of protocol fixation

2016 Year 12 Month 20 Day

Date of IRB

2016 Year 12 Month 20 Day

Anticipated trial start date

2016 Year 12 Month 20 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information

Under analysis and before open


Management information

Registered date

2018 Year 09 Month 22 Day

Last modified on

2023 Year 09 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037884


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name