cerebral infarct ischemic stroke
Conditions
Interventions
Eligible patients with ischemic stroke are randomized to receive either heliox
for 8 hours via a tight sealed face mask upon regular stroke care or regular
stroke care alone. Clinical outcome will b
Sponsors
Gooi-Noord Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: age >= 18 years; clinical anterior circulation ischemic stroke; = 4; pre-admission modified Rankin scale (mRS, dutch version) 20%
Exclusion criteria
Exclusion criteria: eligible for rt-PA thrombolysis; inability to obtain written informed consent; legal incapacity medically instable (blood pressure >230/120 or 120 bpm, mechanical ventilation needed, body temperature above 39*C) intracerebral hemorrhage on admission non-enhanced CT; rapidly improving neurological deficits; pregnancy; impaired renal function (serum creatinin levels > 130 µmol/l) allergic to contrast agent; use of anticoagulation drugs or coagulopathy (PTT > 1.5 times control) use following nephrotoxic medications: aminoglycosids, amfoterecine B or cisplatin contra-indication or intolerance to any used substance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main clinical outcome is the change in neurological deficits between subjects and controls quantified by the National Institute of Health Stroke Scale (NIHSS) at 4 hours. Improvement is defined as a decrease of 4 or more points on the NIHSS. For safety analysis, clinical deterioration - defined as a decrease on the Glasgow Coma Scale of more than 2 points and/or a increase of 4 or more points on NIHSS - is primary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary clinical measures are NIHSS scores at 24 hours, 1 week and 3 months and level physical function measured by modified Rankin Scale (mRS) at 3 months. Independency (mRS | — |
Countries
Netherlands
Outcome results
None listed