Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial

Terminated

Phase 2 Results

Trial Description

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.

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 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.

Trial Stopped: Imbalance in deaths favoring control arm; deaths not attributed to treatment by the blinded external medical monitor.

Conditions

Interventions

  • Normobaric Oxygen Drug
  • Room Air Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: NBO (Normobaric Oxygen)
    Description: Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
    ARM 2: Kind: Experimental
    Label: Room Air
    Description: Room Air, inhaled at 30-45L/min via a facemask for 8 hours
  • NBO (Normobaric Oxygen) Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: NBO (Normobaric Oxygen)
    Description: Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
    ARM 2: Kind: Experimental
    Label: Room Air
    Description: Room Air, inhaled at 30-45L/min via a facemask for 8 hours

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

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

Outcomes

Type Measure Time Frame Safety Issue
Primary 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.
Primary 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. 24 hours Yes
Primary 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. 4 hours after starting treatment No

Sponsors