UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011843 |
|---|---|
| Receipt number | R000013734 |
| Scientific Title | Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2013/09/24 08:51:40 |
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Basic information
Public title
Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Acronym
Effects of cilostazol on cerebral vasospasm
Scientific Title
Effects of cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Scientific Title:Acronym
Effects of cilostazol on cerebral vasospasm
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objective is to evaluate effect of cilostazol on cerebra vasospasm after subarachnoid hemorrhage, change of neurological symptom, side effect, and long-term prognosis by double-blind test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change of cerebra vasospasm before and after treatment
Key secondary outcomes
functional prognosis (m-RS, GOS), evaluation of cerebral infarction with CT or MRI, frequency of adverse event
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cilostazol
Interventions/Control_2
placebo
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient over 20 years-old
patient consented with informed consent from patient's or another person
Key exclusion criteria
patient did not consent to informed consent
patient with drug allergy
pregnant patient or patient of expectant pregnancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Kasuya |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Neurosurgery
Zip code
Address
Nishiogu 2-1-10 Arakawa-ku, Tokyo
TEL
03-3810-1111
kasuyane@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiegru Tani |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Neurosurgery
Zip code
Address
Nishiogu 2-1-10 Arakawa-ku, Tokyo
TEL
03-3810-1111
Homepage URL
http://dnh.twmu.ac.jp
stanine@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Medical Center East Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University Medical Center East Department of Neurosurgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
東京女子医科大学東医療センター脳神経外科 (東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
http://dnh.twmu.ac.jp
Publication of results
Unpublished
Result
URL related to results and publications
http://dnh.twmu.ac.jp
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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 24 | Day |
Last modified on
| 2013 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013734
