Efficacy and Safety of Hemoadsorption for Severe Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- The incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6)
研究概览
简要总结
This is a multicenter, randomized-controlled, open-label, blinded endpoint clinical trial that aims to evaluate the efficacy and safety of hemoadsorption for severe ischemic stroke
详细描述
This is a multicenter, randomized-controlled, open-label, blinded endpoint clinical trial that aims to evaluate the efficacy and safety of hemoadsorption for severe ischemic stroke. During the study period, a total of 116 patients with severe ischemic stroke will be enrolled from 10 centers. To evaluate whether adjunctive hemoadsorption therapy combined with standard treatment can reduce the incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6) at 90 days. Patients in control group will receive standard treatment, and those in the other group will receive standard treatment plus hemoadsorption therapy administered once on days 1, 3, and 5 following enrollment. Study visits will be performed on the day of randomization, at treatment period, at day 7, at day 14 or hospital discharge and at day 90. In addition to the primary endpoint, the study will evaluate whether hemoadsorption can reduce acute-phase inflammatory cytokine levels and decrease the incidence of complications including hemorrhagic transformation, malignant cerebral edema, and pulmonary infections in severe ischemic stroke patients.
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
- None
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
- •1.18 years ≤ age < 80 years; 2.Pre-stroke mRS score ≤ 1; 3.Anterior circulation cerebral infarction within 48 hours of onset, meeting at least one of the following:
- •15≤ NIHSS score ≤32;
- •3\1/2 of the MCA territory; 4.hs-CRP ≥2 mg/L at randomization; 5.If reperfusion therapy is performed, no improvement in NIHSS score (still ≤32) post-treatment; 6.Signed informed consent obtained.
排除标准
- •Hemorrhagic transformation of PH2 type prior to randomization;
- •Brain herniation or decompressive craniectomy performed before randomization;
- •Hemodynamic instability refractory to medical correction (systolic blood pressure <70 mmHg or diastolic blood pressure <50 mmHg) or decompensated heart failure (NYHA Class III or IV);
- •Severe hepatic impairment (defined as ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal) and renal impairment (defined as serum creatinine >1.5 times the upper limit of normal or estimated glomerular filtration rate [eGFR] <50 mL/min);
- •Coagulopathy or thrombocytopenia (platelet count <100×10⁹/L);
- •Deep vein thrombosis (DVT) of the lower extremities before randomization;
- •Life expectancy <90 days due to malignancy;
- •Participation in another drug or device clinical trial within the past 30 days or ongoing enrollment in such trials;
- •Women of childbearing potential with a negative pregnancy test who refuse to use effective contraception, or pregnant/lactating women;
- •Absolute contraindications to hemoadsorption therapy.
研究组 & 干预措施
standard treatment group
standard treatment plus hemoadsorption group
干预措施: Hemoadsorption (Procedure)
结局指标
主要结局
The incidence of severe adverse functional outcomes (modified Rankin Scale [mRS] 4-6)
时间窗: From enrollment to the end of treatment at 90 days
次要结局
未报告次要终点
研究者
Jie Xu
Director
First Affiliated Hospital of Wannan Medical College