UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004411 |
|---|---|
| Receipt number | 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 13:36:08 |
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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
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
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
shirao@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005271
