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

subarachnoid hemorrhage

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

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

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

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name