Prevention and Treatment of Reperfusion Injury After Mechanical Thrombectomy in Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale score
研究概览
简要总结
Ischemic stroke accounts for 80% of all strokes and there is a lack of effective treatment options.Mechanical thrombectomy can significantly improve the vascular recanalization rate and reduce the disability rate of stroke, but the problem of reperfusion injury caused by vascular recanalization is more prominent than before.
The most common manifestation of reperfusion injury is postoperative hemorrhage transformation in the infarct area, which is caused by the inability of blood vessels to tolerate normal perfusion pressure after endothelial cell injury.Therefore, in addition to using necessary strategies to reduce the risk of bleeding before and during surgery, maintaining an appropriate and individualized perfusion pressure after surgery is also an important strategy to prevent and treat postoperative bleeding.
Lead a multicenter, randomized, controlled study looking at Individuation lowers blood pressure.( Drop systolic blood pressure to 90-110mmHg，Blood pressure not lower than 90/60 mm Hg，The reduced blood pressure was maintained for 48 hours). Influence of the incidence of hemorrhage transformation caused by reperfusion injury after mechanical thrombectomy and prognosis (modified Rankin Scale (mRS) score and proportion of patients with mRS≤2) at 48hours, 14 and 90 days after surgery.Thus, provide clinical evidence for blood pressure management strategy after mechanical thrombectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute cerebral infarction with large vessel occlusion within 24 hours of onset .(internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery).
- •18 years≤age≤85 years.
- •CT ruled out cerebral hemorrhage and subarachnoid hemorrhage.
- •Informed consent signed by patient or legal representative.
- •Successful vascular recanalization (defined as modified thrombolysis in cerebral infarction (mTICI)≥2b/3 for cerebral infarction with anterior bleeding).
- •Degree of disease: 6 points≤NIHSS ≤19 points.
排除标准
- •Preoperative or immediate postoperative CT showed active bleeding or was known to have significant bleeding tendency [International Normalized Ratio(INR)>3.0,Platelet count <30×10 9/L.
- •Severe heart, liver and kidney insufficiency.
- •Blood glucose <2.7mmol/L or >22.2mmol/L.
- •Severe hyperemia beyond medication control (>180/105mm Hg).
- •Patients with Alberta early stroke grading CT scores (ASPECT)<
- •Patients with a life expectancy of less than 90 days.
- •Blood pressure is below 90/60 mm Hg.
- •mRS≥3 points .
- •pregnant women.
研究组 & 干预措施
Experimental group
- Lower systolic blood pressure to 90-110 mm Hg.
- Blood pressure not lower than 90/60 mm Hg
- Hypotensive maintenance treatment for 48 hours.
干预措施: Antihypertensive drugs (no restriction on the type of drugs) (Drug)
The control group
- Subjects with basic blood pressure(BBP) > 140/90 mm Hg should have BBP lowered to about 140/90 mm Hg.
- Subjects whose BBP was less than 140/90mm Hg were kept BBP.
干预措施: Antihypertensive drugs (no restriction on the type of drugs) (Drug)
结局指标
主要结局
Modified Rankin Scale score
时间窗: 90 days
Good prognosis rate (mRS ≤ 2 points) at 90 days after surgery in the test and control groups. Modified Rankin Scale scores range from 0 to 6, with a lower score indicating a better prognosis .
次要结局
- The incidence of symptomatic bleeding transformation(48 hours)
- National Institution of Health Stroke Scale scores(48 hours)
- Modified Rankin Scale score(14 days)