UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014696 |
|---|---|
| Receipt number | R000017082 |
| Scientific Title | Effects of intravenous infusion of hydrogen-rich fluid combined with intra-cisternal infusion of magnesium sulfate in severe aneurysmal subarachnoid hemorrhage: a randomized controlled trial |
| Date of disclosure of the study information | 2014/07/29 |
| Last modified on | 2019/02/13 15:18:10 |
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Basic information
Public title
Effects of intravenous infusion of hydrogen-rich fluid combined with intra-cisternal infusion of magnesium sulfate in severe aneurysmal subarachnoid hemorrhage: a randomized controlled trial
Acronym
Effects of intravenous infusion of hydrogen-rich fluid combined with intra-cisternal infusion of magnesium sulfate in severe aneurysmal subarachnoid hemorrhage: a randomized controlled trial
Scientific Title
Effects of intravenous infusion of hydrogen-rich fluid combined with intra-cisternal infusion of magnesium sulfate in severe aneurysmal subarachnoid hemorrhage: a randomized controlled trial
Scientific Title:Acronym
Effects of intravenous infusion of hydrogen-rich fluid combined with intra-cisternal infusion of magnesium sulfate in severe aneurysmal subarachnoid hemorrhage: a randomized controlled trial
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effects of this novel therapeutic strategy on the occurrence of cerebral vasospasm, delayed cerebral ischemia, and clinical outcomes after high-grade subarachnoid hemorrhage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Occurrence of delayed cerebral ischemia
(2) Occurrence of cerebral vasospasm
Key secondary outcomes
(1) Modified Rankin scale score at 3, 6, and 12 months
(2) Biochemical markers (malondialdehyde, neuron-specific enolase, S-100 calcium binding protein B, and C-reactive protein)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
intravenous hydrogen-rich fluid infusion with intra-cisternal magnesium sulfate infusion
Interventions/Control_2
intra-cisternal magnesium sulfate infusion only
Interventions/Control_3
placebo (control group)
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) subarachnoid hemorrhage due to aneurysm rupture (Hunt and Kosnik grade 4 or 5)
(2) aneurysm treated by surgical clipping within 72 hours after the onset
(3) written informed consent from the patient or family member
Key exclusion criteria
(1) severe brain edema
(2) heart dysfunction (New York Heart Association Class III or IV)
(3) renal insufficiency (calculated creatinine clearance rate of less than 30 mL/min), Fisher grade 4 with massive intracerebral hematoma, and rejection of randomization.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Takeuchi |
Organization
National Defense Medical College
Division name
Department of Neurosurgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
042-995-1511
s.takeuchi@room.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Takeuchi |
Organization
National Defense Medical College
Division name
Department of Neurosurgery
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama, Japan
TEL
042-995-1511
Homepage URL
s.takeuchi@room.ocn.ne.jp
Sponsor or person
Institute
Department of Neurosurgery, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, National Defense Medical College
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
| 2014 | Year | 07 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 29 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017082
