NCT05128422已完成不适用
Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke Patients Within 6-24 Hours of Symptom Onset
Capital Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年10月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Early neurologic improvement (ENI) at 24 hours
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficiency of normobaric hyperoxia combined with endovascular treatment for acute ischemic stroke patients with stroke onset 6-24 hours.
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
- •Suspected lage vessel occlusion of acute anterior circulation occlusion; i.e. either the ICA or the M1/M2-segment of the MCA;
- •Stroke symptom onset has been more than 6 hours but not more than 24 hours,and imaging confirmed the existenceof ischemic penumbra;
- •NIHSS score≥6;
- •Alberta Stroke Program Early CT score (ASPECTS) of 6-10 on non- contrast CT;
- •(Level of consciousness) NIHSS score of 0 or 1
- •mRS score was 0-1 before stroke;
- •Informed consent obtained;
排除标准
- •Rapid improvement in neurological status to an NIHSS < 6 or evidence of vessel recanalization prior to randomization;
- •Seizures at stroke onset;
- •Intracranial hemorrhage;
- •Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg, or aggressive treatment intravenous medication)necessary to reduce blood pressure to these limits;
- •Symptoms rapidly improving;
- •Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
- •Platelet count of less than 100,000 per cubic millimeter;
- •CT showed a multiple infarction (low density area greater than 1/3 cerebral hemisphere);
- •severe hepatic or renal dysfunction;
- •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;
- •inability to obtain informed consent;
- •Life expectancy<90 days;
- •Pregnant or breast-feeding women;
- •Unwilling to be followed up or poor compliance for treatment;
- •Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial;
- •Evidence of intracranial tumor;
- •Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol);
- •Patients with upper gastrointestinal bleeding or nausea and vomiting who cannot use oxygen masks;
- •Other circumstances requiring emergency oxygen inhalation;
结局指标
主要结局
Early neurologic improvement (ENI) at 24 hours
时间窗: 24 ± 12 hours
ENI was defined as percent change NIHSS≥30%; Percent change NIHSS was defined as \[(admission NIHSS score-24-hour NIHSS score)x100/admission NIHSS score\];
次要结局
- Mortality(90 ± 14 days after randomization)
- modified Rankin Scale score (mRS)(90 ± 14 days after randomization)
- Revascularization on 24-hour follow-up imaging(24 ± 12 hours hours after randomization)
- Early neurologic deterioration(24 ± 12 hours after randomization)
- Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours(24 ± 12 hours after randomization)
- Symptomatic Intracerebral Hemorrhage(24± 12 hours hours after randomization)
- Stroke recurrence(90 ± 14 days，180 ± 30 days after randomization)
- Cerebral infarct volume(36 ± 12 hours after randomization)
- The 5-level EuroQol five dimensions questionnaire（EQ-5D-5L）score(90 ± 14 days after randomization)
- Delta NIHSS(24 ± 12 hours after randomization)
- National Institutes of Health Stroke Scale(NIHSS) Score(4 hours ± 15 minutes, 24 ± 12 hours; 7 ± 2 days after randomization)
- Barthel Index (BI)(90 ± 14 days after randomization)
- Percent change NIHSS(24 ± 12 hours after randomization)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)Acute Ischemic StrokeNCT05965687Ji Xunming,MD,PhD1,230
招募中
3 期
Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L)Acute Ischemic StrokeNCT05965193Ji Xunming,MD,PhD1,230
招募中
不适用
Normobaric Hyperoxia Stabilizing Ischemic PenumbraAcute Ischemic StrokeNCT05781880Ji Xunming,MD,PhD78
已完成
不适用
Treatment Duration on Normobaric Hyperoxia in Acute Ischemic StrokeStroke, AcuteNeuroprotectionEndovascular TreatmentNCT05404373Capital Medical University100
终止
2 期
Penumbral Rescue by Normobaric O2 Administration in Patients With Ischemic Stroke and Target Mismatch ProFileAcute Ischemic StrokeNCT03500939University Hospital Tuebingen223