Hyperbaric Oxygen After Stroke Thrombectomy: A Multicenter Randomized Trial on Safety and Efficacy

Prior treatment

• Currently involving in the research of other projects related to drugs or medical devices.

Other illness

• Postprocedural imaging identified either procedure-related subarachnoid hemorrhage or hemorrhagic transformation
• Severe heart, liver and kidneys failure
• 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;
• CT angiography or magnetic resonance angiography confirmed the presence of cerebral vasculitis or cerebral vasculitis syndrome;

Lab values

• 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.

Other

• Subjects with HBO contraindications or intolerance
• Based on the medical history, it is suspected that the cerebral embolism is caused by sepsis or infective endocarditis
• Expected lifespan \< 90 days
• Pregnancy
• 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);

• 35-75 years
• The symptoms and signs are consistent with acute anterior circulation ischemic stroke. The immediate postoperative angiographic recanalization grade was ≥ 2b.
• Neurological deficit score at the time of enrollment: 5 ≤ NIHSS ≤ 15 points
• Consciousness status (NIHSS 1a-1b items): 0-1 point
• Pre-stroke functional status (mRS score): 0-1
• Time from surgery to randomization grouping: ≤ 72 hours
• 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; And the area supplied by the middle cerebral artery in the brain is less than 1/3.
• A lberta S troke P rogram E arly C T S core ≥ 6