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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000034242
Receipt No. 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 2018/09/22

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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
Middle name
Last name Fusao Ikawa
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Department of Neurosurgery
Zip code
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
Middle name
Last name Fusao Ikawa
Organization Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name Department of Neurosurgery
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL 082-257-5226
Homepage URL
Email fikawa-nsu@umin.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

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
Address
Tel
Email

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
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 Suspended
Date of protocol fixation
2016 Year 12 Month 20 Day
Date of IRB
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
2020 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
2018 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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