Stroke, AcuteNCT03904017
The Role of Hyperoxia in Acute Ischemic Stroke
A study testing Oxygen in people with Stroke, Acute, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jun 2019to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado
Aurora, Colorado, 80045
University of Colorado Hospital - Memorial Central
Colorado Springs, Colorado, 80909
About this study
Official title: 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.
- Conditions
- Stroke, Acute
- Being tested
- Oxygen, placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
100% Oxygen air
placeboOther
medical air
| Study group | Role | What they receive |
|---|---|---|
| Hyperoxia | Experimental | Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Receives: Other: Oxygen |
| Placebo | Placebo comparator | will receive 15liters per minute medical air via a partial non-rebreather facemask. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (2)
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.
Measured: one week
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.
Measured: baseline to 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start28 Jun 2019
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: Failure to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904017
- Sponsor's protocol ID
- 20-0486
- Status last verified
- May 2024
- First submitted
- 3 Apr 2019
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hyperoxia in the Emergency Department Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03904017
- Acronym / sponsor ID
- 20-0486
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to enroll
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperoxia | Experimental | Other: OxygenWill receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. |
| Placebo | Placebo comparator | Other: placebowill receive 15liters per minute medical air via a partial non-rebreather facemask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen100% Oxygen air | Other | Hyperoxia |
| placebomedical air | Other | Placebo |
Primary outcome
Mean Time to Randomization and Initiation of Intervention
Time frame: 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.
2 secondary outcomes
Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume
Time frame: one week
Change in Mean NIHSS
Time frame: baseline to 24-hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Stroke, Acute, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Time to Randomization and Initiation of Intervention (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.