Stroke, Acute
Conditions
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.
Interventions
OTHEROxygen
100% Oxygen air
OTHERplacebo
medical air
Sponsors
American Heart Association
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form from patient or legal authorized representative (LAR) 2. Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study 3. Males and females (of unlikely childbearing capacity) aged over 18 years. 4. Exhibiting signs and physical examination findings suggestive of an acute ischemic infarction (either a or b) 1. 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 2. 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) 5. Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen
Exclusion criteria
1. Current use of supplemental oxygen 2. Prisoner 3. Documented blood glucose \<70mg/dL 4. Concurrent treatment with another investigational drug or other intervention 5. 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 6. Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease 7. 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 8. Plans for treatment with either IV tPA (alteplase) or endovascular therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time to Randomization and Initiation of Intervention | baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume | one week | 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 | baseline to 24-hours | National Institute of Health Stroke Scale (NIHSS) score will be measured at presentation and 24-hours after intervention. The change in NIHSS from presentation to 24-hours 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hyperoxia Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask.
Oxygen: 100% Oxygen air | 3 |
| Placebo will receive 15liters per minute medical air via a partial non-rebreather facemask.
placebo: medical air | 10 |
| Total | 13 |
Baseline characteristics
| Characteristic | Hyperoxia | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 7 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 17.4 | 71.6 years STANDARD_DEVIATION 14.3 | 68.9 years STANDARD_DEVIATION 15.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 10 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 9 Participants | 11 Participants |
| Region of Enrollment United States | 3 participants | 10 participants | 13 participants |
| Sex: Female, Male Female | 0 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 1 / 10 |
| other Total, other adverse events | 0 / 3 | 0 / 10 |
| serious Total, serious adverse events | 0 / 3 | 0 / 10 |
Outcome results
Primary
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.
Time frame: baseline
Population: The time from ED arrival to initiation of treatment arm was measured in minutes for 3 patients receiving hyperoxia and 10 patients receiving placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperoxia | Mean Time to Randomization and Initiation of Intervention | 96.7 minutes | Standard Deviation 27.3 |
| Placebo | Mean Time to Randomization and Initiation of Intervention | 75.1 minutes | Standard Deviation 14.8 |
Secondary
Change in Mean NIHSS
National Institute of Health Stroke Scale (NIHSS) score will be measured at presentation and 24-hours after intervention. The change in NIHSS from presentation to 24-hours 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
Population: The change in NIHSS from baseline to 24 hours was calculated for 3 hyperoxia and 10 placebo subjects. The mean and standard deviation for both groups was calculated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperoxia | Change in Mean NIHSS | 2 score on a scale | Standard Deviation 0 |
| Placebo | Change in Mean NIHSS | 1.2 score on a scale | Standard Deviation 3.1 |
Secondary
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.
Time frame: one week
Population: Subjects (3 hyperoxia and 6 placebo) who were able to complete the MRI within one week had the volume of the total hypoperfused brain tissue and the final infarct volume measured using RAPID automated software.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperoxia | Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume | 2.17 ratio | Standard Deviation 0.69 |
| Placebo | Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume | 7.76 ratio | Standard Deviation 10.7 |