The Role of Hyperoxia in Acute Ischemic Stroke

NCT03904017 | Terminated Results

• 1 other identifier: 20-0486
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume

  one week

• Change in Mean NIHSS

  baseline to 24-hours

Study Arms (2)

Hyperoxia

EXPERIMENTAL

Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask.

Other: Oxygen

Placebo

PLACEBO COMPARATOR

will receive 15liters per minute medical air via a partial non-rebreather facemask.

Other: placebo

Interventions

Oxygen OTHER

100% Oxygen air

Hyperoxia

placebo OTHER

medical air

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Heart Association: collaborator

Study Sites (2)

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital - Memorial Central

Colorado Springs, Colorado, 80909, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Results Point of Contact

• Title: Layne Dylla
• Organization: University of Colorado

layne.dylla@cuanschutz.edu

303-724-1716

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: June 28, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)