UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of cilostazol on cerebarl vasospasm after subarachnoid hemorrhage
Title of the study (Brief title)	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	Hiroki Ohkuma
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Neurosurgery
Address	5 Zaifu-cho Hirosaki, Aomori
TEL	0172-39-5115
Email	ohkuma@hirosaki-u.ac.jp

Public contact
Name of contact person	Masato Naraoka
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Neurosurgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 30 Day
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

Related information
URL releasing protocol	http://www.med.hirosaki-u.ac.jp/web/index.html
Publication of results	Unpublished
URL releasing results
Results
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