UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2014 Year 12 Month 27 Day
Date of IRB	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
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	2020 Year 04 Month 27 Day

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