UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005752 |
|---|---|
| Receipt number | R000006749 |
| Scientific Title | Molecular hydrogen for ischemic stroke |
| Date of disclosure of the study information | 2011/06/02 |
| Last modified on | 2011/06/02 16:37:03 |
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Basic information
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
Condition
Cerebral infarction
Classification by specialty
| Cardiology | Neurology | Geriatrics |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
Public contact
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
nawa1957@ndmc.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
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
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
防衛医科大学校病院（埼玉県）National Defense Medical College Hospital (Saitama)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 02 | 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
| 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
Other related information
Management 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
