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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | subarachnoid hemorrhage | |
Classification by specialty |
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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 |
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Interventions/Control_1 | The head-viblation method has proposed to the patients after subarachnoid hemorrhage. | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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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 |
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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 | |
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 | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |