NCT07049692招募中不适用
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
Beijing Chao Yang Hospital2 个研究点 分布在 1 个国家目标入组 424 人开始时间: 2026年7月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days
研究概览
简要总结
- 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? 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
- •A lberta S troke P rogram E arly C T S core ≥ 6
排除标准
- •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;
研究组 & 干预措施
Control group
Other
干预措施: Conventional therapy group (Other)
hyperbaric oxygen therapy
Experimental
干预措施: Hyperbaric Oxygen Therapy (Other)
结局指标
主要结局
The proportion of patients with a favorable prognosis (mRS score of 0-2 ) after randomization at 90 (±7) days
时间窗: Day 90 (±7) post-randomization
Modified Rankin Scale (mRS) is defined as the gold standard for measuring global functional outcomes after stroke: 0-1 indicating functional independence, 0-2 favorable prognosis, defining functional independence, 4-5 Severely disabled, 6 death. Higher mRS scores indicate worse prognosis.
次要结局
- Distribution of mRS score [(0, normal)-6(worst)](Day 90 (±7) post-randomization)
- Core infarction volume on Diffusion-Weighted Imaging(Day 10 (±1）post-randomization)
- National Institutes of Health Stroke Scale (NIHSS）score [(0, Normal)-(42, worst)](Day 10(±1) NIHSS score post-randomization)
- mRS score [ (0, Normal)-(6, worst)](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)](Day 90 (±7) post-randomization)
- EuroQol 5-Dimensions(EQ-5D)[(0, worst)-(100, normal)](Day 30(±3), 90(±7), 180(±14), 360(±30) post-randomization)
- Bartherl index (BI)[(0, worst)-(100, normal)](Day 30(±3), 90(±7) , 180(±14) and 360 (±30) post-randomization)
- Stroke recurrence rate(Day 30(±3) , 90(±7d), 180(±14d) and 360(±30) post-randomization)
研究者
Jing Yang
Hyperbaric Oxygen Department
Beijing Chao Yang Hospital
研究点 (2)
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