UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009401 |
|---|---|
| Receipt number | R000011046 |
| Scientific Title | Prospective study for recurrence of chronic subdural hematoma. Comparison of recurrence rate in irrigation solutions. |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2017/12/01 09:15:35 |
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Basic information
Public title
Prospective study for recurrence of chronic subdural hematoma. Comparison of recurrence rate in irrigation solutions.
Acronym
Prospective study for recurrence of chronic subdural hematoma. Comparison of recurrence rate in irrigation solutions.
Scientific Title
Prospective study for recurrence of chronic subdural hematoma. Comparison of recurrence rate in irrigation solutions.
Scientific Title:Acronym
Prospective study for recurrence of chronic subdural hematoma. Comparison of recurrence rate in irrigation solutions.
Region
| Japan |
Condition
Condition
Chronic subdural hematoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective study is conducted to investigate the relationship between recurrence rate and irrigation solutions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We randomly divided two groups(ARTCEREB and normal saline), and evaluated the recurrence rate and period of recurrence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of ARTCEREB
Interventions/Control_2
Use of normal saline
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with surgical treatment for chronic subdural hematoma
Key exclusion criteria
recurrent case
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Uno |
Organization
Kawasaki Medical School
Division name
Neurosurgery
Zip code
Address
577 Matsushima Kurashiki
TEL
086-462-1111
muno@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Uno |
Organization
Kawasaki Medical School
Division name
Neurosurgery
Zip code
Address
Matsushima 577 Kurashiki city
TEL
086-462-1111
Homepage URL
muno@med.kawasaki-m.ac.jp
Sponsor or person
Institute
DepartmentofNeurosurgery, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
DepartmentofNeurosurgery, Kawasaki Medical School
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
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
大熊洋揮 弘前大学 脳神経外科
藤井幸彦 新潟大学 脳神経外科
木内博之 山梨大学 脳神経外科
好本裕平 群馬大学 脳神経外科
岩間 亨 岐阜大学 脳神経外科
野崎和彦 滋賀医科大学 脳神経外科
中瀬裕之 奈良県立医科大学 脳神経外科
宇野昌明 川崎医科大学 脳神経外科
竹島秀雄 宮崎大学 脳神経外科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011046
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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