Back to resultsThe Role of Hyperoxia in Acute Ischemic Stroke
Primary Purpose
Stroke, Acute
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form from patient or legal authorized representative (LAR)
- Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study
- Males and females (of unlikely childbearing capacity) aged over 18 years.
Exhibiting signs and physical examination findings suggestive of an acute ischemic infarction (either a or b)
- A target mismatch profile of CT-perfusion or MRI determined by RAPID automated software to have a ratio of PWITmax>6 lesion volume/DWI lesion volume >1.2 and an NIHSS >/=1
- A RAPID automated software calculated non-contrast CT-head ASPECT score of 10 and LKW ≤12 hours (in patients with symptoms discovered upon waking, the LKW is defined at the midpoint between going to sleep and awakening based on previous studies that suggest most strokes during sleep occur close to awakening)
- Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen
Exclusion Criteria:
- Current use of supplemental oxygen
- Prisoner
- Documented blood glucose <70mg/dL
- Concurrent treatment with another investigational drug or other intervention
- Documented history of any of the following chronic respiratory illness that require pulmonary vasodilators or supplemental oxygen at baseline: Chronic Obstructive Pulmonary Disorder (COPD), Emphysema, Interstitial Lung Disease, Restrictive Lung Disease, Pulmonary Hypertension
- Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease
- Currently being treated for an acute myocardial infarction and/or decompensated heart failure at the onset of initial ED presentation as reported by the ED provider
- Plans for treatment with either IV tPA (alteplase) or endovascular therapy
Sites / Locations
- University of ColoradoRecruiting
- University of Colorado Hospital - Memorial Central
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hyperoxia
Placebo
Arm Description
Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask.
will receive 15liters per minute medical air via a partial non-rebreather facemask.
Outcomes
Primary Outcome Measures
Mean time to randomization and initiation of intervention
Patient arrival to the emergency department will be documented and recorded. They will be screened for participation by study personnel. Once consented and randomized, the time of initiation of intervention will be recorded. The mean time from emergency department presentation to initiation of therapy will be determined.
Secondary Outcome Measures
Mean ratio of the volume of initial hypoperfused tissue to final infarct volume
The total area of hypoperfused brain tissue on initial imaging will be compared to the final infarct volume. This ratio of hypoperfused to final infarct volume will be compared between treatment groups.
Change in mean NIHSS
National Institute of Health Stroke Scale (NIHSS) score will be measured at presentation, 4-hours after intervention and 24-hours after intervention. The change in NIHSS over time will be compared between groups. The NIHSS score is a range of scores from 0-42 with higher scores indicating a more severe stroke and disability.
Full Information
NCT ID
NCT03904017
First Posted
April 3, 2019
Last Updated
April 12, 2022
Sponsor
University of Colorado, Denver
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT03904017
Brief Title
The Role of Hyperoxia in Acute Ischemic Stroke
Official Title
The Role of Hyperoxia in the Emergency Department Treatment of Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being conducted to evaluate the potential therapeutic role of hyperoxia when applied in the immediate ischemic period following a stroke in the controlled Emergency Department setting. The study will evaluate the effects of hyperoxia in stroke patients on the production of markers of free radical damage and inflammatory markers associated with hyperoxic lung injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperoxia
Arm Type
Experimental
Arm Description
Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
will receive 15liters per minute medical air via a partial non-rebreather facemask.
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
100% Oxygen air
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
medical air
Primary Outcome Measure Information:
Title
Mean time to randomization and initiation of intervention
Description
Patient arrival to the emergency department will be documented and recorded. They will be screened for participation by study personnel. Once consented and randomized, the time of initiation of intervention will be recorded. The mean time from emergency department presentation to initiation of therapy will be determined.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Mean ratio of the volume of initial hypoperfused tissue to final infarct volume
Description
The total area of hypoperfused brain tissue on initial imaging will be compared to the final infarct volume. This ratio of hypoperfused to final infarct volume will be compared between treatment groups.
Time Frame
one week
Title
Change in mean NIHSS
Description
National Institute of Health Stroke Scale (NIHSS) score will be measured at presentation, 4-hours after intervention and 24-hours after intervention. The change in NIHSS over time will be compared between groups. The NIHSS score is a range of scores from 0-42 with higher scores indicating a more severe stroke and disability.
Time Frame
baseline to 24-hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form from patient or legal authorized representative (LAR)
Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study
Males and females (of unlikely childbearing capacity) aged over 18 years.
Exhibiting signs and physical examination findings suggestive of an acute ischemic infarction (either a or b)
A target mismatch profile of CT-perfusion or MRI determined by RAPID automated software to have a ratio of PWITmax>6 lesion volume/DWI lesion volume >1.2 and an NIHSS >/=1
A RAPID automated software calculated non-contrast CT-head ASPECT score of 10 and LKW ≤12 hours (in patients with symptoms discovered upon waking, the LKW is defined at the midpoint between going to sleep and awakening based on previous studies that suggest most strokes during sleep occur close to awakening)
Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen
Exclusion Criteria:
Current use of supplemental oxygen
Prisoner
Documented blood glucose <70mg/dL
Concurrent treatment with another investigational drug or other intervention
Documented history of any of the following chronic respiratory illness that require pulmonary vasodilators or supplemental oxygen at baseline: Chronic Obstructive Pulmonary Disorder (COPD), Emphysema, Interstitial Lung Disease, Restrictive Lung Disease, Pulmonary Hypertension
Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease
Currently being treated for an acute myocardial infarction and/or decompensated heart failure at the onset of initial ED presentation as reported by the ED provider
Plans for treatment with either IV tPA (alteplase) or endovascular therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Layne Dylla, MD, PHD
Phone
720-848-6777
Email
layne.dylla@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Layne Dylla, MD, PHD
Phone
720-848-6777
Email
layne.dylla@cuanschutz.edu
Facility Name
University of Colorado Hospital - Memorial Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Enrolling by invitation
12. IPD Sharing Statement
Plan to Share IPD
No
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The Role of Hyperoxia in Acute Ischemic Stroke
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