UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010359 |
|---|---|
| Receipt number | R000012112 |
| Scientific Title | The usefulness of artificial cerebrospinal fluid in recurrence of chronic subdural hematoma |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/03/31 13:12:36 |
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Basic information
Public title
The usefulness of artificial cerebrospinal fluid in recurrence of chronic subdural hematoma
Acronym
The usefulness of artificial cerebrospinal fluid in recurrence of chronic subdural hematoma
Scientific Title
The usefulness of artificial cerebrospinal fluid in recurrence of chronic subdural hematoma
Scientific Title:Acronym
The usefulness of artificial cerebrospinal fluid in recurrence of chronic subdural hematoma
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 evaluate the usefulness of artificial cerebrospinal fluid in the recurrence of chronic subdural hematoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rate within 3 months after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ARTCEREB
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with surgical treatment for chronic subdural hematoma
Key exclusion criteria
1. Patients within 14 days after head injury
2. Patients previous received ipsilateral head surgery
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Iwata |
Organization
Uwajima City Hospital
Division name
Neurosurgery
Zip code
Address
1-1, Goten-machi, Uwajima, Ehime
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Uwajima City Hospital
Division name
Neurosurgery
Zip code
Address
TEL
0895-25-1111
Homepage URL
Sponsor or person
Institute
Uwajima City Hospital
Institute
Department
Personal name
Funding Source
Organization
Uwajima City Hospital
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | 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
| 2013 | Year | 03 | Month | 29 | Day |
Last modified on
| 2015 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012112
