Effect of Heparinization on Intracranial Aneurysm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Size of the ischemic focus
研究概览
简要总结
The goal of this clinical trial is to compare intracranial aneurysm patients. The main question it aims to answer are: Which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. Participants will be randomized to different intraoperative heparinization regimens: (i) 50 U/kg intravenous (IV) at 1-h intervals reduced by half to a minimum of 1000 u/h; (ii) 70 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h. MRI will be performed within 72 h after surgery, and the DWI sequence of MRI will be analyzed. If there is a comparison group: Researchers will compare different intraoperative heparinization protocol groups to see which dose of intraoperative heparin has the best prognosis for use.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years old, less than 75 years old
- •Patients with unruptured intracranial aneurysm were confirmed by DSA.
- •Coagulation function should be normal in the enrolled patients.
排除标准
- •Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation.
- •Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).
研究组 & 干预措施
Low-dose group
The initial dose was 50U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.
干预措施: Heparin sodium (Drug)
High-dose group
The initial dose was 70U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.
干预措施: Heparin sodium (Drug)
结局指标
主要结局
Size of the ischemic focus
时间窗: This will be evaluated within 24 hours after the procedure.
Cranial MRI will be performed on postoperative patients within 24 hours. The presence of high signal on diffusion weighted imaging sequences indicated the occurrence of cerebral infarction.
次要结局
未报告次要终点
研究者
Lu Hua
Professor
The First Affiliated Hospital with Nanjing Medical University