UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031246 |
|---|---|
| Receipt number | R000035676 |
| Scientific Title | Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy - randomized open-labeled multi-institutional prospective study |
| Date of disclosure of the study information | 2018/02/10 |
| Last modified on | 2025/02/17 09:30:26 |
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Basic information
Public title
Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy - randomized open-labeled multi-institutional prospective study
Acronym
Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy
Scientific Title
Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy - randomized open-labeled multi-institutional prospective study
Scientific Title:Acronym
Prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage using cilostazol administration with combination enteral and parental nutrition therapy
Region
| Japan |
Condition
Condition
Aneurysmal subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of cilostazol administration with combination enteral and parental nutrition therapy for prevention of cerebral vasospasm following aneurysmal subarachnoid hemorrhage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Rankin scale 0-2 at discharge
Key secondary outcomes
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
cilostazol administration
Interventions/Control_2
combination enteral and parental nutrition therapy
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. WFNS grade: I-IV
2. No new hemorrhage or infarction on computed tomography images one day after surgical intervention
3. No allergy or adverse effect for cilostazol
4. Written informed consent for attending this study
Key exclusion criteria
1.WFNS grade: V
2. New hemorrhage or infarction on computed tomography images one day after surgical intervention
3. Allergy or adverse effect for cilostazol
4. No contraindication of cilostazol according to package medical insert
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hidehito |
| Middle name | |
| Last name | Kimura |
Organization
Kobe University Hospital
Division name
Neurosurgery
Zip code
650-0017
Address
7-5-1,Kusunoki-cho,Chu-ku,Kobe,Hyogo
TEL
078-382-5966
hkimura@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidehito |
| Middle name | |
| Last name | Kimura |
Organization
Kobe University Hospital
Division name
Neurosurgery
Zip code
650-0017
Address
7-5-1,Kusunoki-cho,Chu-ku,Kobe,Hyogo
TEL
078-382-5966
Homepage URL
hkimura@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Kobe University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Neurosurgery, Kobe University Graduate School of Medicine
Address
7-5-1 Kusunoki-cho, Chuo-ku
Tel
0783825966
hkimura@med.kobe-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
| 2018 | Year | 02 | Month | 10 | 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
| 2018 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2018 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035676
