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Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial

This study has been terminated.
(Imbalance in deaths favoring control arm; deaths not attributed to treatment by the blinded external medical monitor.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414726
First Posted: December 22, 2006
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital
December 21, 2006
December 22, 2006
July 1, 2010
September 16, 2010
October 20, 2017
January 2007
June 2009   (Final data collection date for primary outcome measure)
  • Primary Safety Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 24 Hours (After Therapy) in the Two Groups. [ Time Frame: 24 hours ]
    The NIHSS score ranges from 0 (best score) to 42 (worst score).
  • Primary Efficacy Outcome Measure is a Comparison of the Change in National Institutes of Health Stroke Scale (NIHSS) Scores From Baseline to 4 Hours (During Therapy) in the Two Groups. [ Time Frame: 4 hours after starting treatment ]
    The NIHSS score ranges from 0 (best score) to 42 (worst score).
The primary clinical outcome measure is a comparison of the change in NIHSS scores from baseline to 4 hours (during therapy) in the two groups. The primary neuroimaging outcome measure is a similar comparison of the change in MRI ischemic lesion volumes
Complete list of historical versions of study NCT00414726 on ClinicalTrials.gov Archive Site
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Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
Clinical Trial of Normobaric Oxygen Therapy in Acute Ischemic Stroke
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 standard medical treatment.

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 a blood clot. As a result there is a reduced supply of oxygen and other nutrients leading to permanent brain damage. Normobaric oxygen therapy (NBO, or high-flow oxygen delivered via a facemask) shows promise as a simple, widely accessible, low-cost therapy that can prevent stroke-related brain damage and extend the time window for administering the clot-busting drug t-PA (tissue plasminogen activator), which is the only acute stroke treatment approved by the Food and Drug Administration.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Drug: 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.
  • Drug: 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.
  • Active Comparator: NBO (Normobaric Oxygen)
    Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
    Interventions:
    • Drug: NBO (Normobaric Oxygen)
    • Drug: Room Air
  • Placebo Comparator: Room Air
    Room Air, inhaled at 30-45L/min via a facemask for 8 hours
    Interventions:
    • Drug: NBO (Normobaric Oxygen)
    • Drug: Room Air

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
85
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00414726
R01NS051412( U.S. NIH Grant/Contract )
P50NS051343 ( U.S. NIH Grant/Contract )
Yes
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Aneesh B. Singhal, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Aneesh B Singhal, MD Massachusetts General and Brigham & Women's Hospitals
Massachusetts General Hospital
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP