Hyperbaric oxygen after stroke thrombectomy in acute ischemic stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial evaluates the safety and efficacy of hyperbaric oxygen therapy after endovascular recanalization for acute ischemic stroke. Participants receive 1.6 ATA hyperbaric oxygen for 1 hour daily, five days per week, for a total of 10 sessions, starting within 72 hours of the procedure. Follow-up includes three assessments over 12 months to monitor outcomes and safety. The study compares hyperbaric oxygen plus conventional therapy to conventional therapy alone in patients with preserved pre-stroke function and moderate stroke severity. Eligibility focuses on adults 35–75 with acute anterior circulation stroke and confirmed large vessel occlusion treated by thrombectomy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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;

Where it's running

• Emergency Intensive Care Unit
  Beijing, Beijing Municipality, China Recruiting
• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, China Not yet recruiting

Study contacts

• Study coordinator: Shuyuan Yuan
• Email: shuhua_yuan@126.com
• Phone: +86 18511703665

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.