UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014402 |
|---|---|
| Receipt number | R000016717 |
| Scientific Title | Effects of cilostazol on cerebarl vasospasm after subarachnoid hemorrhage |
| Date of disclosure of the study information | 2014/06/27 |
| Last modified on | 2016/09/11 08:10:28 |
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Basic information
Public title
Effects of cilostazol on cerebarl vasospasm after subarachnoid hemorrhage
Acronym
Effects of cilostazol on cerebral vasospasm
Scientific Title
Effects of cilostazol on cerebarl 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 cerebral 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
occurrence of symptomatic vasospasm
Key secondary outcomes
1) angiographic vasospasm on digital subtraction angiography
2) cerebral infarction due to cerebral vasospasm on CT scan
3) functional outcome (m-RS, GOS)
4) adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Ruptured aneurysm was secured by clipping or coiling within 24 hours after the onset of SAH, and oral administration of placebo or cilostazol was started within 48 hours after the onset of SAH.
3. SAH should be diffuse or localized thick subarachnoid clot on CT scan performed within 24 hours of SAH.
2. clinical grade evaluated by a World Federation of Neurological Surgeons Grade or Hunt and Hess Grade was 1 to 4 before clipping or coiling.
Key exclusion criteria
1. Pre-existing major hepatic, renal, pulmonary or cardiac disease.
2. prior cerebral damage of past history of stroke or traumatic brain injury confirmed by CT scan.
3. focal neurological deficits on admission due to accompanying intracerebral clot.
4. current use of anti-platelet and/or anticoagulant agent.
5. operative neurological deficits arisen due to clipping or coiling procedure.
6.drug allergy
7. pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Ohkuma |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
5 Zaifu-cho Hirosaki, Aomori
TEL
0172-39-5115
ohkuma@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Naraoka |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
5 Zaifu-cho Hirosaki, Aomori
TEL
0172-39-5115
Homepage URL
Nessun@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine Department of Neurosurgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kuroishi General Hospital
Aomori City Hospital
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
弘前大学大学院医学研究科（青森県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
http://www.med.hirosaki-u.ac.jp/web/index.html
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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 27 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 27 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016717
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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