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Stroke, AcutePhase 2NCT04681651

Normobaric Hyperoxia Combined With Endovascular Treatment in Acute Ischemic Stroke (OPENS-2)

A Phase 2 study testing Normobaric Hyperoxia and Endovascular Thrombectomy in people with Stroke, Acute and Neuroprotection, 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 current endovascular treatment has increased the recanalization rate to more than 90%. Even so, the prognosis rate of stroke is still less than 50%. Our previous research confirmed that the neuroprotective effect of Normobaric Hyperoxia (NBO) from multiple perspectives. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Acute, Neuroprotection
What is being tested?
Normobaric Hyperoxia and Endovascular Thrombectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
282 participants
Where
1 siteChina
Study dates
22 Apr 2021to 5 May 2023
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General inclusion criteria
  • It conforms to the indications for endovascular thrombectomy
  • 18 ≦ Age ≦ 80 years old.
  • The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; 10≤NIHSS≤20；
  • (Level of consciousness) NIHSS score 0 or 1;
  • The time from onset to randomization is within 6 hours of onset;
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  • The mRS score before stroke is 0-1;
  • Patient and family members sign informed consent. Image inclusion criteria
  • 1. Preoperative CT or MR or DSA angiography found large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that were consistent with symptoms and signs; 2. ASPECT score ≥ 6 points 3. <1/3 MCA area involvement (confirmed by CT or MRI)

Who cannot join

  • General exclusion criteria
  • Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
  • Seizures at stroke onset;
  • Intracranial hemorrhage;
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
  • Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal;
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  • Platelet count of less than 100,000 per cubic millimeter;
  • Severe hepatic or renal dysfunction;
  • Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg)
  • Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
  • 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;
  • Life expectancy<90 days;
  • Patients who could not complete the 90-day follow-up;
  • Evidence of intracranial tumor;
  • Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
  • Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen.
  • A history of severe allergies to contrast agents;
  • There are any other conditions that are not suitable for endovascular treatment.
  • Image exclusion criteria
  • CTA/MRAshows excessive bending of blood vessels, which may hinder the delivery of the device;
  • Suspected cerebrovascular inflammation based on medical history and CTA/MRA;
  • Suspected aortic dissection based on medical history and CTA/MRA
  • CTA/MRA confirmed multi-vascular area occlusion (such as bilateral anterior circulation or anterior/posterior circulation), or bilateral infarction or multi- regional infarction;
  • CTA/MRAconfirmed moyamoya disease or moyamoya syndrome;
  • CT/MRI confirmed the obvious effect of midline shift
  • CT/MRI confirmed the presence of intracranial tumors

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuan Wu Hospital，Capital Medical University

    Beijing, Beijing Municipality, 100069

Other trials in China

About this study

Official title: A Randomized Controlled Trial Assessing the Efficacy and Safety of Normobaric Hyperoxia for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment

The current endovascular treatment has increased the recanalization rate to more than 90%. Even so, the prognosis rate of stroke is still less than 50%. Our previous research confirmed that the neuroprotective effect of Normobaric Hyperoxia (NBO) from multiple perspectives. However, the clinical study on NBO was not satisfactory, which might be due to the absence of vascular recanalization therapy. Therefore, The investigators conducted this RCT study to further explore the Efficacy and safety of NBO combined with endovascular treatment in patients with acute ischemic stroke.

Being tested
Normobaric Hyperoxia, Sham Normobaric Hyperoxia, Endovascular Thrombectomy
Keywords
Normobaric hyperoxia, Endovascular treatment, Acute ischemic stroke
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

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

  • Normobaric HyperoxiaDrug

    Also called NBO

    Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.

  • Sham Normobaric HyperoxiaDrug

    Also called Sham NBO

    For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%；

  • Endovascular ThrombectomyProcedure or surgery

    Also called EVT

    EVT is the international guidelines for the treatment of acute ischemic stroke with lage vessel occlusion.

Study groups in NCT04681651
Study groupRoleWhat they receive
NBO groupExperimentalNormobaric Hyperoxia combined with endovascular mechanical thrombectomy
Receives: Drug: Normobaric Hyperoxia; Procedure: Endovascular Thrombectomy
Control groupPlacebo comparatorInhale air placebo plus endovascular mechanical thrombectomy
Receives: Drug: Sham Normobaric Hyperoxia; Procedure: Endovascular Thrombectomy

What is being measured

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

  1. Modified Rankin Scale (mRS) score

    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

Secondary outcomes (27)

  1. Cerebral infarct volume

    The infarct volume of cerebral infarct is evaluated by MRI or CT

    Measured: 24-48h after randomization

  2. The proportion of good prognosis

    defined by mRS 0-2

    Measured: 90 ± 14 days after randomization

  3. The proportion of functional independence

    defined by mRS 0-1

    Measured: 90 ± 14 days after randomization

  4. The proportion of severe disability

    defined by mRS 4-6

    Measured: 90 ± 14 days after randomization

  5. Scores assessed by National Institutes of Health Stroke Scale(NIHSS)

    Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits

    Measured: 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization

  6. The proportion of neurological function improvement

    ≥ 4 point reduction in NIHSS score from baseline

    Measured: 24 ± 6 hours after randomization

  7. Successful vessel recanalization

    Successful vessel recanalization is defined by eTICI 2b/2c/3 on final angiogram. Extended treatment in cerebral ischaemia (eTICI) score range from 0 to 3, with higher scores indicating better reperfusion

    Measured: Immediately after procedure

  8. Vessel recanalization

    Vessel recanalization is evaluated by CTA or MRA and assessed by AOL grades. Arterial Occlusive Lesion (AOL) range from 0 to 3, with higher scores indicating better recanalization

    Measured: 24 ± 6 hours after randomization

  9. Arterial oxygen partial pressure

    Laboratory indicators, obtained by arterial blood gas analysis

    Measured: after 4 hours of oxygen therapy

  10. Barthel Index (BI)

    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

  11. EuroQol five dimensions questionnaire（EQ-5D）

    The score ranges from 0 to 100, with higher scores indicating optimal health

    Measured: 90 ± 14 days after randomization

  12. Days of hospitalization

    Length of stay in hospital

    Measured: 90 ± 14 days after randomization

  13. All-cause mortality

    Safety endpoint; the proportion of all patients who died in each group

    Measured: 90 ± 14 days after randomization

  14. Serious adverse events

    Safety endpoint; the proportion of serious adverse events in each group

    Measured: 90 ± 14 days after randomization

  15. Stroke-related mortality

    Safety endpoint; the proportion of stroke related deaths in each group

    Measured: 90 ± 14 days after randomization

  16. Oxygen-related adverse events

    Safety endpoint; the proportion of oxygen-related adverse events in each group, including severe lung infection, pneumothorax, atelectasis, respiratory failure, acute respiratory distress syndrome, and cardiopulmonary arrest

    Measured: 90 ± 14 days after randomization

  17. Adverse events of special interest

    Safety endpoint; the proportion of adverse events of special interest in each group, including malignant brain edema, perioperative myocardial infarction, and acute heart failure

    Measured: 90 ± 14 days after randomization

  18. Symptomatic intracranial hemorrhage

    Safety endpoint; according to ECASS II definition

    Measured: 24 ± 6 hours after randomization

  19. Any intracranial hemorrhage

    Safety endpoint; the proportion of any intracranial hemorrhage in each group

    Measured: 24 ± 6 hours after randomization

  20. Early neurological deterioration (END)

    Safety endpoint; defined as ≥4 point increase in NIHSS score from baseline

    Measured: 24 ± 6 hours after randomization

  21. Systolic and diastolic blood pressure

    Safety endpoint; vital signs

    Measured: 24 ± 6 hours after randomization

  22. Heart rate

    Safety endpoint; vital signs

    Measured: 24 ± 6 hours after randomization

  23. Respiratory rate

    Safety endpoint; vital signs

    Measured: 24 ± 6 hours after randomization

  24. Oxygen saturation

    Safety endpoint; vital signs

    Measured: 24 ± 6 hours after randomization

  25. PH of arterial blood gas analysis

    Safety endpoint

    Measured: after 4 hours of oxygen therapy

  26. PaCO2 of arterial blood gas analysis

    Safety endpoint

    Measured: after 4 hours of oxygen therapy

  27. Lactic acid of arterial blood gas analysis

    Safety endpoint

    Measured: after 4 hours of oxygen therapy

Timeline

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

  1. First posted23 Dec 2020
  2. Study start22 Apr 2021
  3. Primary completion5 May 2023
  4. Study completion5 May 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681651
Sponsor's protocol ID
OPENS-2
Status last verified
Mar 2023
First submitted
6 Dec 2020
Last updated
6 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li W, Lan J, Wei M, Liu L, Hou C, Qi Z, Li C, Jiao L, Yang Q, Chen W, Liu S, Yue X, Dong Q, Yuan H, Gao Z, Wu X, Wen C, Li T, Jiang C, Li D, Chen Z, Shi J, Shi W, Yuan J, Qin Y, Li B, Fisher M, Feng W, Liu KJ, Ji X; OPENS-2 Investigators. Normobaric hyperoxia combined with endovascular treatment for acute ischaemic stroke in China (OPENS-2 trial): a multicentre, randomised, single-blind, sham-controlled trial. Lancet. 2025 Feb 8;405(10477):486-497. doi: 10.1016/S0140-6736(24)02809-5.

    PubMed 39922675

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Normobaric Hyperoxia and Endovascular Thrombectomy in people with Stroke, Acute and Neuroprotection, 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 9 inclusion and 28 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 6 Jul 2023. 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. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Modified Rankin Scale (mRS) score (time frame: 90 ± 14 days after randomization). 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 NCT04681651, 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 6 Jul 2023.

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