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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009401
Receipt No. 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

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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
Email 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
Email muno@med.kawasaki-m.ac.jp

Sponsor
Institute DepartmentofNeurosurgery, Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011046

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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