Clinical trial NCT03904017: 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
Overall status: TERMINATED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2019-04-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Time to Randomization and Initiation of Intervention
timeFrame: baseline
Secondary outcomes:
measure: Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume
timeFrame: one week
measure: Change in Mean NIHSS
timeFrame: baseline to 24-hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: University of Colorado Hospital - Memorial Central
state: Colorado
Study officials:
References: