UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014696
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email s.takeuchi@room.ocn.ne.jp

Sponsor
Institute Department of Neurosurgery, National Defense Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017082


Contact us.