UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004347 |
|---|---|
| Receipt number | R000005204 |
| Scientific Title | Effectiveness of Cilostazol on cerebral vasospasm after subarachnoid hemorrhage |
| Date of disclosure of the study information | 2010/10/07 |
| Last modified on | 2013/04/06 16:20:10 |
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Basic information
Public title
Effectiveness of Cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Acronym
Effect of Cilostazol on vasospasm after subarachnoid hemorrhage
Scientific Title
Effectiveness of Cilostazol on cerebral vasospasm after subarachnoid hemorrhage
Scientific Title:Acronym
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
effect of cilostazol to vasospasm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of delayed ischemic neurological deficits
Key secondary outcomes
1.Angiographical vasospasm on digital subtraction angiography or computed tomographic angiography
2.infarction caused by vasospasm
3.outcome (modified rankin scale)
4.length of hospitalization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
administration of cilostazol
Interventions/Control_2
Administration of non-cilostazol
(ordinary treatment)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients treated by clipping or coiling within 72 hours after SAH.
2. Patients classified as Hunt and kosnik grade 1 to 4.
3. Patients amenable to start cilostazol within 96 hours after SAH and within 48 hours after clipping or coiling.
Key exclusion criteria
1. Patients with congestive heart failure, cilostazol hypersensitivity, pregnancy.
2. Patients with Hemophilia, gastrointestinal bleeding, history of intracerebral hemorrhage.
3. Patients with malignant tumor, liver failure, and renal failure.
4. patients judged improper candidate by doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kinouchi |
Organization
University of Yamanashi, Faculty of Medicine
Division name
Neurosurgery
Zip code
Address
1110, Shimokato, Chuo, Yamanashi
TEL
055-273-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Kanemaru |
Organization
University of Yamanashi, Faculty of Medicine
Division name
Neurosurgery
Zip code
Address
1110, Shimokato, Chuo, Yamanashi
TEL
055-273-1111
Homepage URL
kanemaru@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
山梨大学医学部（山梨県）、山梨県立中央病院（山梨県）、甲府城南病院（山梨県）、関東脳神経外科病院（埼玉県）、那須脳神経外科病院（栃木県）、諏訪中央病院（長野県）、静岡医療センター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2013 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005204
