NBO
Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
[SPOTRIAS]
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Status:
This trial was prematurely terminated by NINDS in May 2009, after 85 subjects had been enrolled. Data analysis is ongoing and we do not have any results as yet.
Purpose:
To compare the safety and efficacy of treating individuals with acute ischemic stroke with normobaric oxygen therapy (NBO)——given within 9 hours of symptom onset——to standard medical treatment. This trial will also assess the therapeutic potential of NBO in extending the time window for administering clot-busting stroke treatment, such as tissue plasminogen activator, t-PA.
Location(s):
Massachusetts
Year Started:
2007
Year Finished:
2009
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
Acute ischemic stroke in whom treatment can potentially be started within 9 hours after symptom onset; NIHSS score 4 or greater.
Exclusion Criteria
Patients being actively considered for intravenous or intra-arterial thrombolysis will be excluded; patients likely to have acute stroke intervention; rapidly improving neurological deficits; known history of severe chronic obstructive pulmonary disease; more than 3 L/min oxygen required to maintain peripheral SaO2 > 92%; NYHA class III heart failure; endotracheal intubation prior to enrollment or impending need for artificial ventilation; Coma (NIHSS item 1a score of 3); suspected seizure at or after onset of stroke, or a known active seizure disorder; blood glucose below 50 mg/dL or greater than 250 mg/dL prior to enrollment; concurrent severe non-stroke medical illness requiring admission to a non-neurological ICU; expected survival less than 90 days; any condition that might limit neurological assessment or follow-up; pre-menopausal women with a positive pregnancy blood test performed at admission;
active participation in another intervention study; proven alternate etiology for stroke-like symptoms.
Patient Involvement:
Participants will be randomly selected to receive either room air or oxygen therapy (at flow rates of 30 to 40 L/min) administered for 8 hours. Neurological function scores and neuroimaging (magnetic resonance imaging, MRI, or computed tomography, CT, scans) will be obtained before, during, and after therapy until 90 days
Primary Outcome:
Primary efficacy outcome measure is a comparison of the change in NIHSS scores from baseline to 4 hours (midway during the 8 hour treatment period)in the two groups. The primary neuroimaging outcome measure is a similar comparison of the change in MRI ischemic lesion volumes. The primary safety outcome measure is a comparison of the change in NIHSS scores from baseline to 24 hours in the two groups.
Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 9/28/2009
Reviewed on: 04/20/2010.
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