Transradial Access for Ruptured Intracranial Aneurysms Embolization--A Multicentre, Randomised, Open-label,Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- The success rate of operation
研究概览
简要总结
The goal of this clinical trail is to compare the difference between transradial access (TRA) and transfemoral access(TFA) for ruptured intracranial aneurysms embolization. The main question it aims to answer is: whether is TRA not inferior to TFA？ In the experimental group, the transradial access (TRA) was used, which was to puncture the radial artery and insert a radial sheath to establish a surgical pathway for embolization of the aneurysm; In the control group, transfemoral access (TFA) was used to embolize the aneurysms, which was to puncture the femoral artery and insert the femoral sheath to establish a surgical pathway for embolizing the aneurysms.The two groups of patients received an oral loading dose of aspirin (300mg) plus clopidogrel (300mg) on the day of surgery, while patients who were unable to take orally were given nasal feeding. During the operation, systemic heparinization was performed with a starting dose of 75U/kg intravenous injection, and the injection was halved every 1h until 1000U. After the operation, protamine neutralizing heparin (1mg protamine neutralizing 100U heparin) was used.
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
- •The age is between 18 and 75 years old.
- •Receiving interventional embolization treatment for intracranial aneurysms.
- •CT scan of the skull shows subarachnoid hemorrhage, and CTA or DSA of the skull shows the presence of an intracranial aneurysm, and it is determined to be aneurysm-related subarachnoid hemorrhage after evaluation by a neurosurgical specialist.
- •At least one side of the bilateral radial arteries can be used to establish surgical access.
- •Evaluation of radial artery patency: Barbeau test type A-C .
- •Hunt-Hess grade 1-3, Glasgow coma score ≥
- •Agreed to participate in this study and willing to cooperate with follow-up. -
排除标准
- •Preoperative upper limb ultrasound or DSA showed radial artery spasm and arteriovenous fistula.
- •Artery CTA or DSA showed vascular anatomical abnormalities such as axillary artery occlusion, and acute angle between the left common carotid artery and the subclavian artery, which may affect the operation.
- •The patient's condition is serious and may die or remain in a coma after surgery, as assessed by a specialist.
- •Received radial or femoral artery puncture examination or treatment within 1 month.
- •The patient refused to participate in the study or cooperate with follow-up.
研究组 & 干预措施
Transradial access
In this group, the transradial access (TRA) was used, which was to puncture the radial artery and insert a radial sheath to establish a surgical pathway for embolization of the aneurysm.
干预措施: transradial access (Procedure)
Transfemoral access
In this group, transfemoral access (TFA) was used to embolize the aneurysms, which was to puncture the femoral artery and insert the femoral sheath to establish a surgical pathway for embolizing the aneurysm.
干预措施: Transfemoral access (Procedure)
结局指标
主要结局
The success rate of operation
时间窗: during the procedure
The success rate of operation
次要结局
- Incidence of hemorrhage events(immediately after the procedure)
- Incidence of ischemic events(immediately after the procedure)
研究者
Lu Hua
Professor
The First Affiliated Hospital with Nanjing Medical University