Reduction of Microembolism After Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms by Administration of Tirofiban：A Randomized, Controlled, Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Microembolism
研究概览
简要总结
The goal of this clinical trial is to investigate whether intravenous injection of tilofiban can reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.The main questions it aims to answer are:
- Is it safe to inject tirofiban intravenously during interventional treatment of intracranial aneurysms？
- What dose of tirofiban is safe and effective?
详细描述
We aim to reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding all personnel who may interfere with the trial results, such as Participant, Care Provider, Investigator and Outcomes Assessor
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
- •Age was between 18 and 75 years old;
- •Unruptured aneurysm with surgical indications;
- •Stent assisted coil embolization treatment was received ;
- •The patient was willing to receive intervention treatment.
排除标准
- •Complicated with hemorrhagic cerebrovascular diseases such as cerebral vascular malformations and moyamoya disease or their medical history;
- •Recent (within 1 year) bleeding symptoms such as gastrointestinal bleeding, clinically significant urinary/reproductive tract bleeding, and skin blueness;
- •Dissecting aneurysm, pseudoaneurysm, and bullous aneurysm;
- •A known history of coagulation disorders, platelet abnormalities, or thrombocytopenia;
- •Platelet count less than 150 × 109/L；
- •A history of major surgical procedures or severe physical trauma within one month;
- •Severe uncontrolled hypertension (systolic blood pressure>160mmHg and/or diastolic blood pressure>100mmHg);
- •Hemorrhagic retinopathy;
- •Chronic hemodialysis;
- •Renal insufficiency.
研究组 & 干预措施
The control group
The same dose of normal saline was used instead of tirofiban.
干预措施: normal saline (Drug)
The intervention group
An intravenous bolus (6µg/kg) over a 3 min period and a maintenance dose of 0.1µg/kg/min for 18 hour were used in this group.
干预措施: Tirofiban (Drug)
结局指标
主要结局
Microembolism
时间窗: Within 72 hours after surgery
Number of microembolism
次要结局
- The incidence of microembolism(Within 48 hours after surgery)
研究者
Lu Hua
Chief physician
The First Affiliated Hospital with Nanjing Medical University