NCT04681651已完成2 期
A Randomized Controlled Trial Assessing the Efficacy and Safety of Normobaric Hyperoxia for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment
Capital Medical University1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2021年4月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS) score
研究概览
简要总结
The current endovascular treatment has increased the recanalization rate to more than 90%. Even so, the prognosis rate of stroke is still less than 50%. Our previous research confirmed that the neuroprotective effect of Normobaric Hyperoxia (NBO) from multiple perspectives. However, the clinical study on NBO was not satisfactory, which might be due to the absence of vascular recanalization therapy. Therefore, The investigators conducted this RCT study to further explore the Efficacy and safety of NBO combined with endovascular treatment in patients with 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria
- •It conforms to the indications for endovascular thrombectomy
- •18 ≦ Age ≦ 80 years old.
- •The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion; 10≤NIHSS≤20；
- •(Level of consciousness) NIHSS score 0 or 1;
- •The time from onset to randomization is within 6 hours of onset;
- •The mRS score before stroke is 0-1;
- •Patient and family members sign informed consent. Image inclusion criteria
- •Preoperative CT or MR or DSA angiography found large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that were consistent with symptoms and signs;
- •ASPECT score ≥ 6 points
- •<1/3 MCA area involvement (confirmed by CT or MRI)
排除标准
- •General exclusion criteria
- •Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
- •Seizures at stroke onset;
- •Intracranial hemorrhage;
- •Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
- •Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal;
- •Platelet count of less than 100,000 per cubic millimeter;
- •Severe hepatic or renal dysfunction;
- •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)
- •Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- •>3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
- •Medically unstable;
- •Life expectancy<90 days;
- •Patients who could not complete the 90-day follow-up;
- •Evidence of intracranial tumor;
- •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.
- •A history of severe allergies to contrast agents;
- •There are any other conditions that are not suitable for endovascular treatment.
- •Image exclusion criteria
- •CTA/MRAshows excessive bending of blood vessels, which may hinder the delivery of the device;
- •Suspected cerebrovascular inflammation based on medical history and CTA/MRA;
- •Suspected aortic dissection based on medical history and CTA/MRA
- •CTA/MRA confirmed multi-vascular area occlusion (such as bilateral anterior circulation or anterior/posterior circulation), or bilateral infarction or multi- regional infarction;
- •CTA/MRAconfirmed moyamoya disease or moyamoya syndrome;
- •CT/MRI confirmed the obvious effect of midline shift
- •CT/MRI confirmed the presence of intracranial tumors
研究组 & 干预措施
NBO group
Experimental
Normobaric Hyperoxia combined with endovascular mechanical thrombectomy
干预措施: Endovascular Thrombectomy (Procedure)
NBO group
Experimental
Normobaric Hyperoxia combined with endovascular mechanical thrombectomy
干预措施: Normobaric Hyperoxia (Drug)
Control group
Placebo Comparator
Inhale air placebo plus endovascular mechanical thrombectomy
干预措施: Sham Normobaric Hyperoxia (Drug)
Control group
Placebo Comparator
Inhale air placebo plus endovascular mechanical thrombectomy
干预措施: Endovascular Thrombectomy (Procedure)
结局指标
主要结局
Modified Rankin Scale (mRS) score
时间窗: 90 ± 14 days after randomization
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
次要结局
- The proportion of good prognosis(90 ± 14 days after randomization)
- All-cause mortality(90 ± 14 days after randomization)
- The proportion of functional independence(90 ± 14 days after randomization)
- Days of hospitalization(90 ± 14 days after randomization)
- Symptomatic intracranial hemorrhage(24 ± 6 hours after randomization)
- Any intracranial hemorrhage(24 ± 6 hours after randomization)
- Early neurological deterioration (END)(24 ± 6 hours after randomization)
- Successful vessel recanalization(Immediately after procedure)
- Vessel recanalization(24 ± 6 hours after randomization)
- Arterial oxygen partial pressure(after 4 hours of oxygen therapy)
- EuroQol five dimensions questionnaire（EQ-5D）(90 ± 14 days after randomization)
- Serious adverse events(90 ± 14 days after randomization)
- Stroke-related mortality(90 ± 14 days after randomization)
- Barthel Index (BI)(90 ± 14 days after randomization)
- Cerebral infarct volume(24-48h after randomization)
- The proportion of severe disability(90 ± 14 days after randomization)
- Scores assessed by National Institutes of Health Stroke Scale(NIHSS)(24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization)
- The proportion of neurological function improvement(24 ± 6 hours after randomization)
- Oxygen-related adverse events(90 ± 14 days after randomization)
- Adverse events of special interest(90 ± 14 days after randomization)
- Heart rate(24 ± 6 hours after randomization)
- Systolic and diastolic blood pressure(24 ± 6 hours after randomization)
- PaCO2 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)
- PH of arterial blood gas analysis(after 4 hours of oxygen therapy)
- Lactic acid of arterial blood gas analysis(after 4 hours of oxygen therapy)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (1)
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