Status:
TERMINATED
Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is 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 stand...
Detailed Description
Stroke is the third leading cause of death and the leading cause of disability in the United States. Ischemic stroke is caused by a blockage of blood flow to one or more brain arteries, usually due to...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years.
- 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
- Patients being actively considered for intravenous or intra-arterial thrombolysis will be excluded.
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00414726
Start Date
January 1 2007
End Date
June 1 2009
Last Update
October 20 2017
Active Locations (2)
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1
Massachusetts General Hospital, ACC-729C
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital, 75 Francis Street
Boston, Massachusetts, United States, 02115