Helium in Ischemic Stroke.
Suspended
- Conditions
- Helium, ischemic stroke.helium, ischemische beroerte.
- Registration Number
- NL-OMON25537
- Lead Sponsor
- TergooiziekenhuizenRijksstraatweg 1, 1261 AN Blaricum,The Netherlands.Phone: +31 35 539 11 11
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Age >=18 years, not eligible for rt-PA;
2. Clinical anterior circulation ischemic stroke diagnosed by an independent physisian;
Exclusion Criteria
1. Eligible for rt-PA thrombolysis;
2. Inability to obtain written informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Main safety endpoint: Clinical deterioration, defined as a decrease on the Glasgow Coma Scale of more than 2 points and/or a decrease of 4 or more points on the NIHSS;<br /><br>2. Primary clinical endpoint: Comparison of the change in neurological deficits, quantified by the National Institute of Health Stroke Scale (NIHSS) during helium therapy. <br>
- Secondary Outcome Measures
Name Time Method 1. Safety endpoint: Death by any cause and total and specific serious adverse events, including symptomatic heamorrhagic transformation or intracrananial heamorrhage;<br /><br>2. Secondary clinical endpoints: Neurological deficits at 4 hours, 24 hours, 1 week and at 3 months, quantified on NIHSS and the level of dependency measures on the modified Rankin Scale (mRS) at three months.