Can pressurized oxygen boost stroke recovery?
NCT ID NCT07626450
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) soon after emergency clot removal can improve recovery in people with severe stroke. Researchers plan to enroll 420 adults aged 18–80 who had a large-vessel blockage stroke and received endovascular treatment within 24 hours. Participants will receive either standard care plus three sessions of hyperbaric oxygen or standard care alone, and their functional outcomes will be measured at 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hyperbaric oxygen therapy
- What this could lead to
- If it works, this could become a standard add-on treatment to improve functional recovery after a severe stroke.
- What could go wrong
- This is a mid-sized trial testing a therapy that has not been proven for this use. The benefit may be small or absent, and hyperbaric oxygen carries risks like ear or sinus pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 420 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18\~80 years; 2. Clinically diagnosed as acute large vessel occlusive ischemic stroke, suitable for and received endovascular treatment according to current clinical guidelines; 3. The onset of stroke or the last normal time to the time of endovascular treatment ≤ 24 hours; 4. Pre-stroke mRS score of 0 or 1; 5. Baseline NIHSS score before endovascular treatment ≥ 6 points in the anterior circulation or ≥10 points in the posterior circulation; 6. CTA, MRA, or DSA angiography before endovascular treatment confirmed occlusion of large vessels (internal carotid artery, middle cerebral artery M1 segment, basilar artery), consistent with symptoms and signs; 7. The corresponding anterior circulation ASPECTS score or posterior circulation pc-ASPECTS score ≥ 6 points; 8. The pontine midbrain index (PMI) of patients with acute basilar artery occlusion ≤3; 9. Patients or their family members sign the informed consent form. Exclusion Criteria: 1. Patients with extensive bleeding or severe increase in infarct area, midline displacement (\>0.5cm), etc. during endovascular treatment, who plan to undergo bone valve decompression or ventricular drainage; 2. Known bleeding risk factors, including coagulation factor deficiency, or receiving anticoagulant therapy, INR\>3.0 or APTT \> 3 times normal or platelet count less than 50×10⁹/L; 3. Severe hepatic or renal dysfunction (severe hepatic dysfunction refers to ALT or AST \> 3 times the upper limit of the normal range, severe renal dysfunction refers to serum creatinine Cr \>1.5 times the upper limit of the normal range); 4. Females of pregnancy, or positive pregnancy test prior to randomization; 5. Severe persistent and medication-uncontrollable hypertension (systolic blood \> 185 mmHg or diastolic blood \> 110 mmHg) 6. Baseline blood glucose of \<50 mg/dL (2.78 mmol/L) or \>400 mg/dL (22.20 mmol/L); 7. The oxygen required to maintain 95% of peripheral arterial oxygen saturation (SaO2) under the current medium-term management guidelines \> 3L/min; 8. End-stage disease other than the nervous system, life expectancy \< 90 days; 9. Participating in other drug or medical device clinical trials; 10. CT or MR suggests intracranial tumors (other than meningiomas) or other high-risk intracranial vascular malformations; 11. Patients with anemia, polycythemia or other conditions requiring urgent oxygen; 12. Unable to cooperate with hyperbaric oxygen therapy, or have other diseases that are not suitable for hyperbaric oxygen therapy (such as active/chronic obstructive pulmonary disease, acute respiratory distress syndrome, tension pneumothorax, tension pneumocephalus, etc.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital
RECRUITINGBeijing, Beijing Municipality, 100071, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a bad mood or infection trigger a major stroke? scientists investigate
- Balloon trick after clot removal may shield the brain
- Stroke neuroprotection trial pulled before it started
- Stroke hope: clot removal may work even days later