Molecular hydrogen for ischemic stroke
Not Applicable
Recruiting
- Conditions
- Cerebral infarction
- Registration Number
- JPRN-UMIN000005752
- Lead Sponsor
- Department of Neurosurgery, National Defense Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Patients with acute ischemic stroke beyond 24 hours of symptom onset.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method modified Rankin scale (mRS) (days 7, 30, and 90), the NIHSS (days 7 and 90), and the Barthel Index (days 7, 30, and 90)
- Secondary Outcome Measures
Name Time Method 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.