UMIN-CTR Clinical Trial

Public title

Molecular hydrogen for ischemic stroke

Acronym

Hydrogen for cerebral ischemia

Scientific Title

Molecular hydrogen for ischemic stroke

Scientific Title:Acronym

Hydrogen for cerebral ischemia

Region

Japan

Condition

Cerebral infarction

Classification by specialty

Cardiology	Neurology	Geriatrics
Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the safety and efficacy of molecular hydrogen for ischemic stroke

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

modified Rankin scale (mRS) (days 7, 30, and 90), the NIHSS (days 7 and 90), and the Barthel Index (days 7, 30, and 90)

Key secondary outcomes

Safety Assessments
Vital signs were recorded at enrollment and at specified times throughout the infusion and follow-up periods. Routine laboratory data and ECGs were performed at the time of enrollment, at 24 and 72 hours, and on day 7 and were analyzed centrally (ECGs at day 7 were performed only if abnormal at 72 hours). To assess any effect of hydrogen on hemorrhagic transformation after alteplase administration, brain imaging was repeated after 72 hours in patients who were receiving concomitant treatment with alteplase. Symptomatic hemorrhagic transformation was defined as an increase in the NIHSS score of at least 4 points within 36 hours, plus evidence of any blood on neuroimaging after treatment with alteplase. Patients meeting criteria for progressive stroke (NIHSS increase of 4 points within 72 hours) or new stroke in the first week were also reimaged.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

Intravenous drip infusion of hydrogen-rich saline

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

120

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients were eligible for enrollment if they were 18 years or older and had a clinical diagnosis of acute ischemic stroke within 24 hours of symptom onset. They had to score at least 6 on the National Institutes of Health Stroke Scale (NIHSS) with at least 2 points for limb weakness. All patients received appropriate routine stroke care as per local treatment practices, including alteplase for eligible patients presenting 3 hours from onset; patients receiving alteplase had to commence the study drug before the alteplase infusion.

Key exclusion criteria

Patients with acute ischemic stroke beyond 24 hours of symptom onset.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Nawashiro, M.D.,D.M.Sc.

Organization

National Defense Medical College (NDMC)

Division name

Department of Neurosurgery

Zip code

Address

3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Hiroshi Nawashiro, M.D.,D.M.Sc.

Organization

National Defense Medical College (NDMC)

Division name

Department of Neurosurgery

Zip code

Address

3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan

TEL

04-2995-1656

Homepage URL

Email

nawa1957@ndmc.ac.jp

Institute

Department of Neurosurgery, National Defense Medical College

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Ken-o-Tokorozawa Hospital
Tokorozawa Central Hospital
Self-Defense Forces Central Hospital
Kuki General Hospital
Nishijima Hospital

Name of secondary funder(s)

MiZ Co., Ltd.
CEO Fumitake Satoh
16-5, Zengyo 1-chome, Fujisawa-shi, Kanagawa-ken,
251-0871
Japan

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

防衛医科大学校病院（埼玉県）National Defense Medical College Hospital (Saitama)

Date of disclosure of the study information

2011

Year

06

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2011

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

06

Month

01

Day

Last follow-up date

2013

Year

06

Month

01

Day

Date of closure to data entry

2013

Year

12

Month

01

Day

Date trial data considered complete

2013

Year

12

Month

01

Day

Date analysis concluded

2013

Year

12

Month

01

Day

Other related information

Registered date

2011

Year

06

Month

10

Day

Last modified on

2011

Year

06

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006749