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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011843
Receipt No. R000013734
Scientific Title Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Date of disclosure of the study information 2013/12/01
Last modified on 2013/09/24

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Basic information
Public title Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Acronym Effects of cilostazol on cerebral vasospasm
Scientific Title Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Scientific Title:Acronym Effects of cilostazol on cerebral vasospasm
Region
Japan

Condition
Condition subarachnoid hemorrhage
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Objective is to evaluate effect of cilostazol on cerebra vasospasm after subarachnoid hemorrhage, change of neurological symptom, side effect, and long-term prognosis by double-blind test.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes change of cerebra vasospasm before and after treatment
Key secondary outcomes functional prognosis (m-RS, GOS), evaluation of cerebral infarction with CT or MRI, frequency of adverse event

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 cilostazol
Interventions/Control_2 placebo
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria patient over 20 years-old
patient consented with informed consent from patient's or another person
Key exclusion criteria patient did not consent to informed consent
patient with drug allergy
pregnant patient or patient of expectant pregnancy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Kasuya
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Neurosurgery
Zip code
Address Nishiogu 2-1-10 Arakawa-ku, Tokyo
TEL 03-3810-1111
Email kasuyane@dnh.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiegru Tani
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Neurosurgery
Zip code
Address Nishiogu 2-1-10 Arakawa-ku, Tokyo
TEL 03-3810-1111
Homepage URL http://dnh.twmu.ac.jp
Email stanine@dnh.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Medical Center East Department of Neurosurgery
Institute
Department

Funding Source
Organization Tokyo Women's Medical University Medical Center East Department of Neurosurgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 東京女子医科大学東医療センター脳神経外科 (東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 01 Day

Related information
URL releasing protocol http://dnh.twmu.ac.jp
Publication of results Unpublished

Result
URL related to results and publications http://dnh.twmu.ac.jp
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
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
2019 Year 12 Month 01 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2020 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 09 Month 24 Day
Last modified on
2013 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013734

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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