UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015760 |
|---|---|
| Receipt number | R000018339 |
| Scientific Title | The safe and effectiveness of continuous cisternal irrigation with artificial magnesium solution in patient with aneurysmal subarachnoid hemorrhage. |
| Date of disclosure of the study information | 2014/11/26 |
| Last modified on | 2014/11/26 16:00:40 |
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Basic information
Public title
The safe and effectiveness of continuous cisternal irrigation with artificial magnesium solution in patient with aneurysmal subarachnoid hemorrhage.
Acronym
Effects of continuous intracisternal magnesium injection for vasospam in subarachnoid hemorrhage.
Scientific Title
The safe and effectiveness of continuous cisternal irrigation with artificial magnesium solution in patient with aneurysmal subarachnoid hemorrhage.
Scientific Title:Acronym
Effects of continuous intracisternal magnesium injection for vasospam in subarachnoid hemorrhage.
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of continuous intracisternal magnesium injection for vasospam in subarachnoid hemorrhage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Functional outcome at 3months after onset (modified Rankin Scale, Glasgow outcome scale)
Key secondary outcomes
1. chronological changes of Mg2+ concentration in serum and CSF
2. infarction caused by vasospasm
3. MCA velocity measured by TCD
4. Angiographical vasospasm on digital subtraction angiography
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 not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
continuous cisternal irrigation with artificial magnesium solution
Interventions/Control_2
ordinary treatment
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aneurysmal subarachnoid hemorrhage
2. Patients treated by clipping via craniotomy within 72 hours after SAH
3. Patients classified as WFNS SHA Grade 1 to 4
4. Patients classified as Fisher CT group 2 and 3
Key exclusion criteria
1. Age older than 80 years
2. Patients with severe surgical complication
3. Patients with pregnancy
4. Patients with malignant tumor, liver failure, and renal failure
5. Patients judged improper candidate by doctor
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Yamamoto |
Organization
Juntendo Univerisity Shizuoka Hospital
Division name
Department of Neurosurgery
Zip code
Address
1129 Nagaoka, Izunokuni-City, Shizuoka
TEL
055-948-3111
tyamamoto@med-juntendo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuji Yamamoto |
Organization
Junetndo University Shizuoka Hospital
Division name
Department of Neurosurgery
Zip code
Address
1129 Nagaoka, Izunokuni-City, Shizuoka
TEL
055-948-3111
Homepage URL
tyamamoto@med-juntendo.jp
Sponsor or person
Institute
Juntendo Univerisity Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
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
順天堂大学医学部附属静岡病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 26 | 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
| 2007 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 26 | Day |
Last modified on
| 2014 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018339
| 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 |
