Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 269
- 试验地点
- 1
- 主要终点
- rate of intracranial hemorrhage
研究概览
简要总结
This study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.Patients receiving surgical treatment for SICH were divided into groups using the random machine method. In addition to conventional treatment for spontaneous intracerebral hemorrhage, patients in the group of early initiation of antiplatelet therapy were given conventional dose of aspirin (100mg, qd) antiplatelet therapy starting from the 3rd day after surgery.An independent group of investigators evaluated cardiac, cerebral and peripheral vascular events and bleeding events at four different time points.To evaluate the benefits and safety of early postoperative initiation of antiplatelet therapy in patients with spontaneous intracerebral hemorrhage.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old.
- •nontraumatic spontaneous intracerebral hemorrhage.
- •postoperative patients with high risk of MACCPE:(1)previous history of cerebral infarction or TIA. (2)previous history of coronary heart disease or myocardial infarction.(3) use ASCVD Risk Estimator Plus（http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/） to assess the risk of ischemic events for patients with no previous history of cerebral infarction, TIA, or coronary heart diseases or myocardial infarction,10 years risk>10% is defined as a high risk of cardiovascular ischemic events(4)The Caprini Risk Scale is used to assess the risk of venous thrombosis in the lower extremities.Score>2 is defined as a high risk of venous thrombosis.
- •patients who received neurosurgical procedures to remove the hematoma, including craniotomy, endoscopic hematoma removal and hematoma aspiration.
- •patients who signed informed consent.
- •no history of allergy to salicylic acid preparation.
- •patients who complete the preintervention assessment and meet the fellow criteria:(1)postoperative head CT showed no new infarction or hemorrhage(2)postoperative venous ultrasound of the lower extremity did not reveal deep vein thrombosis.(3)postoperative electrocardiogram and myocardial enzyme examination did not show acute myocardial ischemia or myocardial infarction.
排除标准
- •there are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc.) or tumors in the area of bleeding or the bleeding is suspected to be related to these lesions.
- •ischemic stroke with hemorrhagic conversion.
- •secondary bleeding due to venous embolism.
- •the malignant tumor is expected to have a survival of no more than 3 months.
- •take antithrombotic agents((Vitamin K antagonists (warfarin) new anticoagulants(Dabigatun Rivaroxaban))) in addition to antiplatelet agents.
- •previous history of thrombocytopenia or coagulation disorders.
- •previous history of atrial fibrillation.
研究组 & 干预措施
E-STAR group
干预措施: Antiplatelet Agents (Drug)
结局指标
主要结局
rate of intracranial hemorrhage
时间窗: 90 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
时间窗: 90 days after surgery
次要结局
未报告次要终点
研究者
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital