UMIN-CTR Clinical Trial

Basic information
Public title	Preventing effect of head-viblation method on cerebral vasospasm after subarachnoid hemorrhage.
Acronym	Head-viblation method on cerebral vasospasm
Scientific Title	Preventing effect of head-viblation method on cerebral vasospasm after subarachnoid hemorrhage.
Scientific Title:Acronym	Head-viblation method on cerebral vasospasm
Region	Japan

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

Objectives
Narrative objectives1	This study is conducted to examine cerebral vasospasm for patients treated with head-viblation method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of hemoglobin in cerebrospinal fluid from patients treated with head-viblation method
Key secondary outcomes	Incidence of cerebral vasospasm in the head-viblation method group. Clinical outcome (The Modified Rankin Scale; mRS) 30 days sfter the onset of the patients treated with head-viblation method. Incidence of the hydrocephalus in the head-viblation method group.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The head-viblation method has proposed to the patients after subarachnoid hemorrhage.
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients after aneurysmal subarachnoid hemorrhage. The patients treated with surgical clipping or coil embolization within 72 hours after the onset of subarachnoid hemorrhage.
Key exclusion criteria	The patients who were not treated with cisternal or lumbar drain.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michiyasu Suzuki
Organization	Yamaguchi University School of Medicine
Division name	Department of Neurosurgery and Clinical Neuroscience
Zip code
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2295
Email	neurosur@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Satoshi Shirao
Organization	Yamaguchi University School of Medicine
Division name	Department of Neurosurgery and Clinical Neuroscience
Zip code
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL	0836-22-2295
Homepage URL
Email	shirao@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University School of Medicine
Institute
Department

Funding Source
Organization	Yamaguchi University 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
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	山口大学医学部附属病院(山口県)

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 01 Day

Related information
URL releasing protocol
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	Open public recruiting
Date of protocol fixation	2010 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2012 Year 10 Month 31 Day
Date of closure to data entry	2012 Year 10 Month 31 Day
Date trial data considered complete	2012 Year 10 Month 31 Day
Date analysis concluded	2015 Year 04 Month 20 Day

Other
Other related information

Management information
Registered date	2010 Year 10 Month 19 Day
Last modified on	2015 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005271

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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