Hyperbaric oxygen after clot-removal in large vessel strokes
Official title: HyperBaric Oxygen Therapy After ACute Thrombectomy in Acute Ischemic strOke Due to Large Vessel occlusioN
Run by Beijing Tiantan Hospital · NCT07626450 · Data updated 2026-11-12
In people who have an acute stroke due to a large vessel blockage and were treated with endovascular therapy, this trial tests whether adding hyperbaric oxygen after the procedure helps more people recover.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 2026 |
| Main results expected | September 2027 |
| Study ends | October 2027 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07626450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with acute large vessel occlusion stroke who received endovascular treatment and meet specific imaging and functional criteria.
✕Probably not a fit
Patients who do not show improved functional outcomes or who have characteristics outside the eligibility criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter trial compares hyperbaric oxygen therapy plus standard care to standard care alone following endovascular treatment for acute ischemic stroke due to large vessel occlusion. It is prospective and randomized with a 1:1 ratio, and uses an endpoint-blinded design. The main outcome is functional status at about 90 days, measured by the modified Rankin Scale. Eligible participants are adults 18–80 who had a confirmed large vessel occlusion and successful endovascular treatment, with baseline impairment and imaging meeting specific criteria.
Why it matters
Potential benefit: If successful, patients may regain more independence after stroke with the addition of hyperbaric oxygen therapy.
How similar studies have gone: Prior studies in similar contexts suggest potential benefits of hyperbaric oxygen, but results in acute stroke remain mixed and further confirmation is needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.).
Where it's running
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Ning Ma, MD — Beijing Tiantan Hospital
- Study coordinator: Ning Ma, MD
- Email: maning_03@hotmail.com
- Phone: 13581889908
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Intra-arterial tenecteplase to improve small-vessel blood flow after mechanical clot removal
This study will try a single weight-based intra-arterial dose of tenecteplase after successful mechanical thrombectomy to improve microvascular blood flow in adults with anterior large-vessel ischemic stroke.
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Using the Anaconda ANA5 device for treating acute ischemic stroke
This study is testing a new device called the Anaconda ANA5 to see if it can help people with acute ischemic stroke get better treatment results compared to standard methods.
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Registry for Endovascular Thrombectomy in Extra-Large Stroke Patients
This study is trying to see how well a procedure called endovascular thrombectomy works for people with very large strokes to help improve their outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.