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

Официальное название

Evaluation of the Efficacy and Safety of Hyperbaric Oxygen in Patients After Endovascular Treatment for Acute Ischemic Stroke: A Multicenter, Open-label, Randomized Controlled Clinical Trial

Обзор

1. The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment 2. The main questions it aims to answer is: Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment? 3. 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.

Вмешательства

• Другое Hyperbaric Oxygen Therapy
  1.6 atmosphere absolute (1.6 ATA), HBO treatment administrated via mask or hood, one 60 minutes session, once daily, 5 days a week (can be non consecutive days), with a total of 10 sessions.
• Другое Conventional therapy group
  Conventional therapy

Первичные конечные точки

• The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days [Срок оценки: Day 90 (±7) post-randomization]

Вторичные конечные точки (7)

• Core infarction volume on Diffusion-Weighted Imaging [Срок оценки: Day 10 (±1）post-randomization]
• National Institutes of Health Stroke Scale (NIHSS）score [(0, Normal)-(42, worst)] [Срок оценки: Day 10(±1) NIHSS score post-randomization]
• mRS score [ (0, Normal)-(6, worst)] [Срок оценки: Day 10 (±1）post-randomization; Day 30(±3) post-randomization; Day 180(±14) post-randomization; Day 360(±30) post-randomization.]
• Distribution of mRS score [(0, normal)-6(worst)] [Срок оценки: Day 90 (±7) post-randomization]
• Bartherl index (BI)[(0, worst)-(100, normal)] [Срок оценки: Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization]
• EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)] [Срок оценки: Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization]
• Stroke recurrence rate [Срок оценки: Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Emergency Intensive Care Unit — Пекин
• Beijing Chaoyang Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07049692 · 2025-KE-357-2 · 2025-3-4-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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