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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024417
Receipt No. R000018906
Scientific Title Comparative study of cilostazol that influence cerebral blood flow velocity and outcome in subarachnoid hemorrhage patients
Date of disclosure of the study information 2016/10/16
Last modified on 2019/09/21

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Basic information
Public title Comparative study of cilostazol that influence cerebral blood flow velocity and outcome in subarachnoid hemorrhage patients
Acronym Influence of cilostazol on CBF and outcome in SAH
Scientific Title Comparative study of cilostazol that influence cerebral blood flow velocity and outcome in subarachnoid hemorrhage patients
Scientific Title:Acronym Influence of cilostazol on CBF and outcome in SAH
Region
Japan

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

Objectives
Narrative objectives1 Cerebral vasospasm is most important deuteropathy that influence the outcome of subarachnoid hemorrhage (SAH). Several researchers reported that cilostazol prevented cerebral vasospasm and improved the outcome of SAH. But the change of hemodynamics that was produced by cilostazol have not been clear.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cerebral blood flow velocity and cerebral blood flow volume calculated by preoperative and postoperative (day 7 to 11) cerebral angiography. Clinical outcome at day 30 and 90 after aneurysm rupture.
Key secondary outcomes Incidence and severity of cerebral vasospasm

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intake of Cilostazol (200mg per day)
Interventions/Control_2 Intake oflactose (200mg per day)
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 Aneurysmal subarachnoid patients
Key exclusion criteria Non-aneurysmal subarachnoid hemorrhage
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Norihito
Middle name
Last name Shimamura
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code 036-5302
Address 5-Zaihuchou Hirosaki
TEL 0172-39-5115
Email shimab@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Norihito
Middle name
Last name Shimamura
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code 036-5302
Address 5-Zaihuchou Hirosaki
TEL 0172-39-5115
Homepage URL
Email shimab@hirosaki-u.ac.jp

Sponsor
Institute Department of Neurosurgery
Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of Neurosurgery Hirosaki University Graduate School of Medicine
Address 5-Zaihuchou Hirosaki
Tel 0172-39-5115
Email nougeka@hirosaki-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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2014 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 15 Day
Last modified on
2019 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018906

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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