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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014402
Receipt No. R000016717
Scientific Title Effects of cilostazol on cerebarl vasospasm after subarachnoid hemorrhage
Date of disclosure of the study information 2014/06/27
Last modified on 2016/09/11

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Basic information
Public title Effects of cilostazol on cerebarl vasospasm after subarachnoid hemorrhage
Acronym Effects of cilostazol on cerebral vasospasm
Scientific Title Effects of cilostazol on cerebarl 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 cerebral 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 occurrence of symptomatic vasospasm
Key secondary outcomes 1) angiographic vasospasm on digital subtraction angiography
2) cerebral infarction due to cerebral vasospasm on CT scan
3) functional outcome (m-RS, GOS)
4) adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Ruptured aneurysm was secured by clipping or coiling within 24 hours after the onset of SAH, and oral administration of placebo or cilostazol was started within 48 hours after the onset of SAH.
3. SAH should be diffuse or localized thick subarachnoid clot on CT scan performed within 24 hours of SAH.
2. clinical grade evaluated by a World Federation of Neurological Surgeons Grade or Hunt and Hess Grade was 1 to 4 before clipping or coiling.
Key exclusion criteria 1. Pre-existing major hepatic, renal, pulmonary or cardiac disease.
2. prior cerebral damage of past history of stroke or traumatic brain injury confirmed by CT scan.
3. focal neurological deficits on admission due to accompanying intracerebral clot.
4. current use of anti-platelet and/or anticoagulant agent.
5. operative neurological deficits arisen due to clipping or coiling procedure.
6.drug allergy
7. pregnancy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ohkuma
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 5 Zaifu-cho Hirosaki, Aomori
TEL 0172-39-5115
Email ohkuma@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Naraoka
Organization Hirosaki University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 5 Zaifu-cho Hirosaki, Aomori
TEL 0172-39-5115
Homepage URL
Email Nessun@hirosaki-u.ac.jp

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

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

Other related organizations
Co-sponsor Kuroishi General Hospital
Aomori City Hospital
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 弘前大学大学院医学研究科(青森県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 27 Day

Related information
URL releasing protocol http://www.med.hirosaki-u.ac.jp/web/index.html
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 Completed
Date of protocol fixation
2010 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 30 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 06 Month 27 Day
Date trial data considered complete
2014 Year 06 Month 27 Day
Date analysis concluded
2014 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 27 Day
Last modified on
2016 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016717

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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