The Role of Hyperoxia in Acute Ischemic Stroke

  • STATUS
    Recruiting
  • End date
    May 28, 2023
  • participants needed
    200
  • sponsor
    University of Colorado, Denver
Updated on 28 April 2022
ischemic stroke

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.

Details
Condition Stroke, Acute
Treatment Oxygen, Placebo
Clinical Study IdentifierNCT03904017
SponsorUniversity of Colorado, Denver
Last Modified on28 April 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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