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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004411
Receipt No. R000005271
Scientific Title Preventing effect of head-viblation method on cerebral vasospasm after subarachnoid hemorrhage.
Date of disclosure of the study information 2010/11/01
Last modified on 2015/04/20

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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
Last 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
1st 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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