NCT05965687已完成3 期
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)
Ji Xunming,MD,PhD1 个研究点 分布在 1 个国家目标入组 1,230 人开始时间: 2023年8月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,230
- 试验地点
- 1
- 主要终点
- Utility-weighted modified Rankin scale scores
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
详细描述
In this study, cases of acute ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The Normobaric Hyperoxia(NBO) group receive basic intravenous thrombolysis and given 100% oxygen inhalation at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. The control group receive basic intravenous thrombolysis and given oxygen inhalation at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. The investigators aimed to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous thrombolysis for acute ischemic stroke.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years;
- •The time from onset to randomization is within 4.5 hours of onset;
- •The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
- •Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;
- •Pre-stroke mRS score≤1 points;
- •Informed consent from the patient or surrogate.
排除标准
- •Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
- •Past history of intracranial hemorrhage;
- •Rapid neurological function improvement, NIHSS score less than 5 points;
- •Presence of proximal arterial occlusion on computed tomographic angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral artery(MCA)-M1, and vertebrobasilar arteries);
- •Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery);
- •Intended to proceed endovascular treatment;
- •Pregnant women, or planning to become pregnant during the trial;
- •A history of severe head trauma or stroke within 3 months;
- •A history of intracranial or spinal surgery within 3 months;
- •A history of gastrointestinal or urinary bleeding within 3 weeks;
- •two weeks of major surgery;
- •Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
- •Active visceral bleeding;
- •Intracranial tumors, large intracranial aneurysms;
- •Aortic arch dissection was found;
- •Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood Pressure >110 mmHg);
- •Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol);
- •Oral warfarin anticoagulant with international normalized ratio(INR)>1.7 or prothrombin time(PT)>15 s;
- •Heparin treatment was received within 24 h;
- •Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
- •Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
- •Hereditary or acquired bleeding constitution;
- •Onset with seizures;
- •Severe liver and kidney dysfunction;
- •Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- •Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation;
- •Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen;
- •Life expectancy < 1 year;
- •Patients who could not complete the 90-day follow-up;
- •Participation in other clinical trials within 3 months prior to screening;
- •Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
研究组 & 干预措施
NBO group
Experimental
Normobaric Hyperoxia combined with intravenous thrombolysis
干预措施: Normobaric Hyperoxia (Procedure)
NBO group
Experimental
Normobaric Hyperoxia combined with intravenous thrombolysis
干预措施: Intravenous thrombolysis(rt-PA) (Drug)
Control group
Placebo Comparator
Nasal oxygen combined with intravenous thrombolysis
干预措施: Intravenous thrombolysis(rt-PA) (Drug)
Control group
Placebo Comparator
Nasal oxygen combined with intravenous thrombolysis
干预措施: Nasal oxygen (Procedure)
结局指标
主要结局
Utility-weighted modified Rankin scale scores
时间窗: 90±7 days after randomization
Utility-weighted modified Rankin scale scores
次要结局
- modified rankin scale (mRS) score(90±7 days after randomization)
- Cerebral infarct volume(24-48hours after randomization)
- EuroQol five dimensions questionnaire（EQ-5D）(baseline before randomization,7 ± 2 days,30 ± 7 days,90 ± 7 days after randomization)
- The proportion of neurological function improvement(24 ± 6 hours after randomization)
- Barthel Index (BI)(30 ± 7 days,90 ± 7 days after randomization)
- Days of hospitalization(30 ± 7 days after randomization)
- Asymptomatic intracranial hemorrhage(24 ± 6 hours after randomization)
- Systematic bleeding(24 ± 6 hours after randomization)
- Oxygen-related adverse events(90 ± 7 days after randomization)
- Unit costs(7 ± 2 days, 30 ± 7 days,90 ± 7 days after randomization)
- Excellent functional outcome(90±7 days after randomization)
- Scores assessed by National Institutes of Health Stroke Scale(NIHSS)(4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization)
- Proportion of subjects with modified rankin scale (mRS) 0-1(30 ± 7 days after randomization)
- Symptomatic intracranial hemorrhage(24 ± 6 hours after randomization)
- PH2 intracranial hemorrhage(24 ± 6 hours after randomization)
- Any intracranial hemorrhage(24 ± 6 hours after randomization)
- Early neurological deterioration(24 ± 6 hours after randomization)
- PaCO2 of arterial blood gas analysis(after 4 hours of oxygen therapy)
- Potential of hydrogen(PH) of arterial blood gas analysis(after 4 hours of oxygen therapy)
- Good functional outcome(90 ± 7 days after randomization)
- Proportion of subjects with modified rankin scale (mRS) 0-3(90 ± 7 days after randomization)
- Adverse events/serious adverse events(24 ± 12 hours, 7 ± 2 days, 90± 7 days after randomization)
- Systolic and diastolic blood pressure(24 ± 6 hours after randomization)
- Heart rate(24 ± 6 hours after randomization)
- Stroke-related mortality(90 ± 7 days after randomization)
- All-cause mortality(90 ± 7 days after randomization)
- PaO2 of arterial blood gas analysis(after 4 hours of oxygen therapy)
- Concentration of Lactic acid of arterial blood gas analysis(after 4 hours of oxygen therapy)
- Respiratory rate(24 ± 6 hours after randomization)
- Oxygen saturation(24 ± 6 hours after randomization)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (1)
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