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StrokeNCT05128422

Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke

A study testing Normobaric oxygen therapy in people with Stroke and Endovascular Treatment, run by Capital Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Endovascular Treatment, Neuroprotection
What is being tested?
Normobaric oxygen therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
27 Oct 2021to 15 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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

  • age≥18;
  • Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA;
  • Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra;
  • NIHSS score≥6;
  • Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT;
  • (Level of consciousness) NIHSS score of 0 or 1
  • mRS score was 0-1 before stroke;
  • Informed consent obtained;

Who cannot join

  • Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization;
  • Seizures at stroke onset;
  • Intracranial hemorrhage;
  • Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits;
  • Symptoms rapidly improving;
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
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  • Platelet count of less than 100,000 per cubic millimeter;
  • CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere);
  • severe hepatic or renal dysfunction;
  • active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
  • >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)#95% as per current stroke management guidelines;
  • medically unstable;
  • inability to obtain informed consent;
  • Life expectancy<90 days;
  • Pregnant or breast-feeding women;
  • Unwilling to be followed up or poor compliance for treatment;
  • Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
  • Evidence of intracranial tumor;
  • Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);
  • Patients with upper gastrointestinal bleeding or nausea and vomiting who cannot use oxygen masks;
  • Other circumstances requiring emergency oxygen inhalation;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital of Capital Medical University

    Beijing

Other trials in China

About this study

Official title: Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients Within 6-24 Hours of Symptom Onset

The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.

Being tested
Normobaric oxygen therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normobaric oxygen therapyOther

    it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours.This therapy should begin in the emergency room as early as possible when patients meet the inclusion criteria and are randomized to the experimental group

Study groups in NCT05128422
Study groupRoleWhat they receive
NBO+EVT groupExperimentalNormobaric hyperoxia Combined with Endovascular therapy group were given 100% oxygen via a face mask initiated before vascular recanalization (10L/min for 4h) . In addition, the patient will be given endovascular therapy surgery.
Receives: Other: Normobaric oxygen therapy
EVT groupNo interventionThe Endovascular therapy group were given room air. And the patient will also be given endovascular therapy surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early neurologic improvement (ENI) at 24 hours

    ENI was defined as percent change NIHSS≥30%; Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score];

    Measured: 24 ± 12 hours

Secondary outcomes (13)

  1. National Institutes of Health Stroke Scale(NIHSS) Score

    the NIHSS is a stroke severity score that is composed of 11 items; range from 0 to 42, higher values indicate more severe deficits

    Measured: 4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization

  2. modified Rankin Scale score (mRS)

    secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death)

    Measured: 90 ± 14 days after randomization

  3. Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours

    secondary clinical efficacy endpoint;the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits)

    Measured: 24 ± 12 hours after randomization

  4. Barthel Index (BI)

    secondary clinical efficacy endpoint;the BI is an ordinal disability score of 10 categories(range from 0 to 100, higher values indicate better prognosis);

    Measured: 90 ± 14 days after randomization

  5. Revascularization on 24-hour follow-up imaging

    secondary imaging efficacy endpoint;Successful recanalization was defined as mTICI 2b or 3

    Measured: 24 ± 12 hours hours after randomization

  6. Early neurologic deterioration

    NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;

    Measured: 24 ± 12 hours after randomization

  7. Symptomatic Intracerebral Hemorrhage

    imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification

    Measured: 24± 12 hours hours after randomization

  8. Mortality

    clinical safety endpoint;

    Measured: 90 ± 14 days after randomization

  9. Stroke recurrence

    clinical safety endpoint;

    Measured: 90 ± 14 days，180 ± 30 days after randomization

  10. The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score

    secondary clinical efficacy endpoint, Quality of Life score; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: 90 ± 14 days after randomization

  11. Delta NIHSS

    Delta NIHSS was defined (admission NIHSS score-24-hour NIHSS score).

    Measured: 24 ± 12 hours after randomization

  12. Percent change NIHSS

    Percent change NIHSS was defined as [(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score]

    Measured: 24 ± 12 hours after randomization

  13. Cerebral infarct volume

    Infarct volume is evaluated mainly through brain MRI(DWI) or CT

    Measured: 36 ± 12 hours after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start27 Oct 2021
  3. Primary completion15 Oct 2023
  4. Study completion15 Oct 2023

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128422
Sponsor's protocol ID
OPENS-1A
Status last verified
Oct 2023
First submitted
28 Oct 2021
Last updated
31 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li W, Hu W, Wang S, Chen Z, Ding J, Ma Q, Liu KJ, Feng W, Liu S, Ji X. Adjunctive Normobaric Hyperoxia With Endovascular Thrombectomy for Acute Stroke at 6 to 24 Hours: A Phase IIb Randomized Trial. Stroke. 2026 Aug;57(8):2265-2275. doi: 10.1161/STROKEAHA.125.055019. Epub 2026 Jul 6.

    PubMed 42403344

Questions about this trial

What is this clinical trial studying?

A study testing Normobaric oxygen therapy in people with Stroke and Endovascular Treatment, run by Capital Medical University at 1 site in China.

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 8 inclusion and 21 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Early neurologic improvement (ENI) at 24 hours (time frame: 24 ± 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05128422, which also lists 1 linked publication.

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 31 Jul 2024.

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