Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
NCT ID: NCT00414726
Last Updated: 2017-10-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
85 participants
INTERVENTIONAL
2007-01-31
2009-06-30
Brief Summary
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Detailed Description
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The primary goal of this trial is to compare the safety and therapeutic efficacy of NBO (started within 9 hours of symptom onset) to standard medical treatment with Room Air. We aim to enroll a total of 240 individuals with acute ischemic stroke less than 9 hours after symptom onset, at the Massachusetts General and Brigham and Women's Hospitals in Boston. Participants will be randomly selected to receive either room air (RA, control) or NBO (active treatment) at flow rates of 30-45L/min administered via a face mask 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.
This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit individuals with stroke.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NBO (Normobaric Oxygen)
Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
NBO (Normobaric Oxygen)
High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
Room Air
Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
Room Air
Room Air, inhaled at 30-45L/min via a facemask for 8 hours
NBO (Normobaric Oxygen)
High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
Room Air
Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
Interventions
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NBO (Normobaric Oxygen)
High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
Room Air
Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
Eligibility Criteria
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Inclusion Criteria
* Acute ischemic stroke in whom treatment can potentially be started within 9 hours after symptom onset. If the symptom onset time is unknown, the time of onset will be defined as the midpoint between the time when the subject was last seen neurologically intact, and when found to have a neurological deficit.
* National Institutes of Health Stroke Scale (NIHSS) score 4 or greater.
Exclusion Criteria
* Patients likely to have acute stroke intervention such as carotid endarterectomy or stent or angioplasty, hemicraniectomy, etc.
* Rapidly improving neurological deficits (transient ischemic attack).
* Known history of severe chronic obstructive pulmonary disease (Forced Expiratory Vital Capacity less than 1.0 or oxygen dependent).
* More than 3 L/min oxygen required to maintain peripheral arterial oxygen saturation above 92%.
* New York Heart Association Class III heart failure.
* Endotracheal intubation prior to enrollment or impending need for artificial ventilation.
* Coma (National Institutes of Health Stroke Scale 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 intensive care unit
* Expected survival less than 90 days.
* Any condition that might limit neurological assessment or follow-up in the opinion of the investigator.
* Pre-menopausal women with a positive pregnancy blood test performed at admission.
* Inability to obtain consent from the patient or legally authorized representative.
* Active participation in another intervention study (e.g. investigational drug trial).
* Proven alternate etiology for stroke-like symptoms.
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Aneesh B. Singhal, MD
Associate Professor of Neurology
Principal Investigators
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Aneesh B Singhal, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General and Brigham & Women's Hospitals
Locations
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Massachusetts General Hospital, ACC-729C
Boston, Massachusetts, United States
Brigham and Women's Hospital, 75 Francis Street
Boston, Massachusetts, United States
Countries
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References
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Singhal AB, Benner T, Roccatagliata L, Koroshetz WJ, Schaefer PW, Lo EH, Buonanno FS, Gonzalez RG, Sorensen AG. A pilot study of normobaric oxygen therapy in acute ischemic stroke. Stroke. 2005 Apr;36(4):797-802. doi: 10.1161/01.STR.0000158914.66827.2e. Epub 2005 Mar 10.
Kim HY, Singhal AB, Lo EH. Normobaric hyperoxia extends the reperfusion window in focal cerebral ischemia. Ann Neurol. 2005 Apr;57(4):571-5. doi: 10.1002/ana.20430.
Singhal AB, Dijkhuizen RM, Rosen BR, Lo EH. Normobaric hyperoxia reduces MRI diffusion abnormalities and infarct size in experimental stroke. Neurology. 2002 Mar 26;58(6):945-52. doi: 10.1212/wnl.58.6.945.
Singhal AB, Ratai E, Benner T, Vangel M, Lee V, Koroshetz WJ, Schaefer PW, Sorensen AG, Gonzalez RG. Magnetic resonance spectroscopy study of oxygen therapy in ischemic stroke. Stroke. 2007 Oct;38(10):2851-4. doi: 10.1161/STROKEAHA.107.487280. Epub 2007 Aug 30.
Singhal AB. Oxygen therapy in stroke: past, present, and future. Int J Stroke. 2006 Nov;1(4):191-200. doi: 10.1111/j.1747-4949.2006.00058.x.
Fujiwara N, Murata Y, Arai K, Egi Y, Lu J, Wu O, Singhal AB, Lo EH. Combination therapy with normobaric oxygen (NBO) plus thrombolysis in experimental ischemic stroke. BMC Neurosci. 2009 Jul 15;10:79. doi: 10.1186/1471-2202-10-79.
Regenhardt RW, Gonzalez RG, He J, Lev MH, Singhal AB. Symmetric CTA Collaterals Identify Patients with Slow-progressing Stroke Likely to Benefit from Late Thrombectomy. Radiology. 2022 Feb;302(2):400-407. doi: 10.1148/radiol.2021210455. Epub 2021 Nov 2.
Related Links
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Specialized Program of Translational Research in Acute Stroke website