UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024417 |
|---|---|
| Receipt number | R000018906 |
| Scientific Title | Comparative study of cilostazol that influence cerebral blood flow velocity and outcome in subarachnoid hemorrhage patients |
| Date of disclosure of the study information | 2016/10/16 |
| Last modified on | 2020/04/27 15:48:11 |
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Basic information
Public title
Comparative study of cilostazol that influence cerebral blood flow velocity and outcome in subarachnoid hemorrhage patients
Acronym
Influence of cilostazol on CBF and outcome in SAH
Scientific Title
Comparative study of cilostazol that influence cerebral blood flow velocity and outcome in subarachnoid hemorrhage patients
Scientific Title:Acronym
Influence of cilostazol on CBF and outcome in SAH
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cerebral vasospasm is most important deuteropathy that influence the outcome of subarachnoid hemorrhage (SAH). Several researchers reported that cilostazol prevented cerebral vasospasm and improved the outcome of SAH. But the change of hemodynamics that was produced by cilostazol have not been clear.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow velocity and cerebral blood flow volume calculated by preoperative and postoperative (day 7 to 11) cerebral angiography. Clinical outcome at day 30 and 90 after aneurysm rupture.
Key secondary outcomes
Incidence and severity of cerebral vasospasm
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Intake of Cilostazol (200mg per day)
Interventions/Control_2
Intake oflactose (200mg per day)
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
Aneurysmal subarachnoid patients
Key exclusion criteria
Non-aneurysmal subarachnoid hemorrhage
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Norihito |
| Middle name | |
| Last name | Shimamura |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
036-5302
Address
5-Zaihuchou Hirosaki
TEL
0172-39-5115
shimab@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Shimamura |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
036-5302
Address
5-Zaihuchou Hirosaki
TEL
0172-39-5115
Homepage URL
shimab@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery
Hirosaki University Graduate 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
Department of Neurosurgery Hirosaki University Graduate School of Medicine
Address
5-Zaihuchou Hirosaki
Tel
0172-39-5115
nougeka@hirosaki-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2014 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 15 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018906
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
