Hyperbaric Oxygen After Stroke Thrombectomy: A Multicenter Randomized Trial on Safety and Efficacy (NOTICE-1)

Capital Medical University

Status

Not yet enrolling

Conditions

Acute Ischemic Stroke

Treatments

Other: Conventional therapy group

Other: Hyperbaric Oxygen Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07049692

2025-KE-357-2

2025-3-4-2 (Registry Identifier)

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment
The main questions it aims to answer is:

Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment?
Participants will:

receive HBO (1.6 Atmosphere Absolute，1.6ATA)，Once a day, for 1 hour each time, for 5 days a week (it can be non-consecutive days), the total course of treatment is 10 times.

undergo three scheduled face to face or telephone follow-up assessments during the 12-month period following HBO.

Enrollment

424 estimated patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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;