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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000014696 |
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Date of registration:
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29/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 - 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 |
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Date of first enrolment:
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2014/07/29 |
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Target sample size:
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450 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017082 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Satoru Takeuchi |
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Address:
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3-2 Namiki, Tokorozawa, Saitama, Japan
Japan |
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Telephone:
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042-995-1511 |
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Email:
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s.takeuchi@room.ocn.ne.jp |
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Affiliation:
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National Defense Medical College Department of Neurosurgery |
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Name:
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Satoru Takeuchi |
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Address:
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3-2 Namiki, Tokorozawa, Saitama, Japan
Japan |
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Telephone:
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042-995-1511 |
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Email:
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s.takeuchi@room.ocn.ne.jp |
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Affiliation:
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National Defense Medical College Department of Neurosurgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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subarachnoid hemorrhage
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Intervention(s)
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intravenous hydrogen-rich fluid infusion with intra-cisternal magnesium sulfate infusion
intra-cisternal magnesium sulfate infusion only
placebo (control group)
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Primary Outcome(s)
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(1) Occurrence of delayed cerebral ischemia (2) Occurrence of cerebral vasospasm
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Secondary Outcome(s)
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(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)
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Source(s) of Monetary Support
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Department of Neurosurgery, National Defense Medical College
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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