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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004347
Receipt No. R000005204
Scientific Title Effectiveness of Cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Date of disclosure of the study information 2010/10/07
Last modified on 2013/04/06

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Basic information
Public title Effectiveness of Cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Acronym Effect of Cilostazol on vasospasm after subarachnoid hemorrhage
Scientific Title Effectiveness of Cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Scientific Title:Acronym Effect of Cilostazol on vasospasm after subarachnoid hemorrhage
Region
Japan

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

Objectives
Narrative objectives1 effect of cilostazol to vasospasm
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of delayed ischemic neurological deficits
Key secondary outcomes 1.Angiographical vasospasm on digital subtraction angiography or computed tomographic angiography
2.infarction caused by vasospasm
3.outcome (modified rankin scale)
4.length of hospitalization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 administration of cilostazol
Interventions/Control_2 Administration of non-cilostazol
(ordinary treatment)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients treated by clipping or coiling within 72 hours after SAH.
2. Patients classified as Hunt and kosnik grade 1 to 4.
3. Patients amenable to start cilostazol within 96 hours after SAH and within 48 hours after clipping or coiling.
Key exclusion criteria 1. Patients with congestive heart failure, cilostazol hypersensitivity, pregnancy.
2. Patients with Hemophilia, gastrointestinal bleeding, history of intracerebral hemorrhage.
3. Patients with malignant tumor, liver failure, and renal failure.
4. patients judged improper candidate by doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kinouchi
Organization University of Yamanashi, Faculty of Medicine
Division name Neurosurgery
Zip code
Address 1110, Shimokato, Chuo, Yamanashi
TEL 055-273-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Kanemaru
Organization University of Yamanashi, Faculty of Medicine
Division name Neurosurgery
Zip code
Address 1110, Shimokato, Chuo, Yamanashi
TEL 055-273-1111
Homepage URL
Email kanemaru@yamanashi.ac.jp

Sponsor
Institute University of Yamanashi, Faculty of Medicine
Institute
Department

Funding Source
Organization None
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 山梨大学医学部(山梨県)、山梨県立中央病院(山梨県)、甲府城南病院(山梨県)、関東脳神経外科病院(埼玉県)、那須脳神経外科病院(栃木県)、諏訪中央病院(長野県)、静岡医療センター(静岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results 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
2009 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 30 Day
Date analysis concluded
2013 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 06 Day
Last modified on
2013 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005204

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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