UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008225 |
|---|---|
| Receipt number | R000009692 |
| Scientific Title | The effect of cilostazol on vasospasm after subarachnoid hemorrhage: a role for spreading depolarization |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2014/12/22 16:44:00 |
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Basic information
Public title
The effect of cilostazol on vasospasm after subarachnoid hemorrhage: a role for spreading depolarization
Acronym
The effect of cilostazol on vasospasm after subarachnoid hemorrhage
Scientific Title
The effect of cilostazol on vasospasm after subarachnoid hemorrhage: a role for spreading depolarization
Scientific Title:Acronym
The effect of cilostazol on vasospasm after subarachnoid hemorrhage
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 and cerebral microcirculation for patients treated with cilostazol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of cerebral vasospasm in the cilostazol treated group.
Key secondary outcomes
Clinical outcome (The Modified Rankin Scale; mRS) 30 days and 90 days after the onset of the patients treated with cilostazol.
Incidence of cerebral vasospasm detected on angiography.
Cerebral microcirculation of patients treated with cilostazol.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients of subarachnoid hemorrhage are treated with cilostazol after clipping/coi embolization of ruptured cerebral aneurysm.
Interventions/Control_2
The patients of subarachnoid hemorrhage are not treated with cilostazol after clipping/coi embolization of ruptured cerebral aneurysm.
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 embolizaion within 72 hours after the onset of subarachnoid henorrhage.
Key exclusion criteria
The patients treated with surgical clipping or coil embolizaion after 72 hours of the onset of subarachnoid henorrhage.
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
shirao@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadahiro Nomura |
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
| 2012 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 21 | Day |
Last modified on
| 2014 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009692
