The Role of Hyperoxia in Acute Ischemic Stroke

The Role of Hyperoxia in the Emergency Department Treatment of Acute Ischemic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Other: Oxygen; Other: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Layne Dylla, MD, PHD; Phone Number: 720-848-6777; Email: layne.dylla@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Layne Dylla, MD, PHD; Phone Number: 720-848-6777; Email: layne.dylla@cuanschutz.edu
    • Colorado Springs, Colorado, United States, 80909
      • Enrolling by invitation
      • University of Colorado Hospital - Memorial Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperoxia; Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask.	Other: Oxygen; 100% Oxygen air
Placebo Comparator: Placebo; will receive 15liters per minute medical air via a partial non-rebreather facemask.	Other: placebo; medical air

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one week
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.	baseline to 24-hours

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: American Heart Association

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2019
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Stroke; Ischemic Stroke; Hyperoxia
• Other Study ID Numbers: 20-0486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No