Evaluation of the Efficacy and Safety of Hyperbaric Oxygen Combined With Endovascular Treatment in Patients With Acute Ischemic Stroke

Launched by BEIJING CHAO YANG HOSPITAL · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) to a standard treatment called endovascular thrombectomy (a procedure to remove blood clots in the brain) can help people who have had an acute ischemic stroke. The main goal is to see if this combined treatment can improve recovery and be safe for patients.

To join the study, participants need to be between 18 and 75 years old and have recently had a specific type of stroke caused by a blockage in a large brain artery. They must have undergone the clot-removal procedure and be generally alert and able to communicate. During the study, participants will receive either hyperbaric oxygen or high-flow oxygen once a day for 10 days. They will also have follow-up phone calls over the next year to check on their progress. People with certain health issues, such as severe heart or kidney problems, bleeding disorders, or uncontrolled high blood pressure, will not be eligible. This study is not yet recruiting patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-75 years
• • Patients presenting clinical manifestations of acute anterior circulation ischemic stroke (6-20 NIHSS points) who underwent endovascular thrombectomy
• • Consciousness status (NIHSS 1a-1b items): 0-1 points
• • Pre-stroke functional status (mRS score): 0-1
• • Time from onset to randomization ≤ 2 weeks
• • Patient or legal representative who signed the informed consent form
• • Preoperative CT angiography or magnetic resonance angiography confirmed large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that was consistent with the symptoms and signs
• • A lberta S troke P rogram E arly C T S core ≥ 6
• Exclusion Criteria:
• • Subjects with HBO contraindications or intolerance
• • Postprocedural imaging identified either procedure-related subarachnoid hemorrhage or hemorrhagic transformation
• • Based on the medical history, it is suspected that the cerebral embolism is caused by sepsis or infective endocarditis
• • Expected lifespan \< 90 days
• • Severe heart, liver and kidneys failure
• • Pregnancy
• • Hereditary or acquired bleeding tendency, deficiency of coagulation factors, recent use of oral anticoagulants with an international normalized ratio (INR) \> 3 or activated partial thromboplastin time (APTT) exceeding the normal value by more than 3 times
• • Baseline platelet count \< 50×10 9/L
• • Baseline blood glucose is less than 2.78 mmol/L or greater than 22.2 mmol/L.
• • Unstable vital signs (heart rate ≤ 50 beats/min or ≥ 120 beats/min, oxygen saturation ≤ 90%, respiration ≥ 30 breaths/min or ≤ 10 breaths/min);
• • Hypertension that cannot be controlled by medication: Systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
• • Suspected of having acute myocardial infarction;
• • Currently involving in the research of other projects related to drugs or medical devices.
• • CT or MRI scans revealed intracranial tumors (except for cerebellar meningiomas) and intracranial arteriovenous malformations.
• • Based on the medical history and CT or MRI findings, a diagnosis of internal carotid artery dissection or aortic dissection is suspected;
• • Based on the medical history and CT or MRI findings, cerebral vasculitis is suspected.
• • Based on the clinical evidence of multiple vascular regions being occluded (either in the bilateral anterior circulation or anterior/posterior circulation) or bilateral infarction or multi-region infarction as detected by CT angiography or magnetic resonance angiography;
• • CT or magnetic resonance imaging shows a significant midline shift effect (\> 0.5 cm);
• • CT angiography or magnetic resonance angiography confirmed the presence of cerebral vasculitis or cerebral vasculitis syndrome;