Multi-center，Single Blind，Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery
研究概览
简要总结
In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine.
详细描述
This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two parts, and each part divide into two stage, on the stage of registration study. This study is a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative activated coagulation time Changes in detail, to observe the effect of activated coagulation time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours, purpose to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation. On the stage of randomized controlled study. This study is a multicenter, single-blind, prospective, randomized controlled study. Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens on activated coagulation time safety coverage rate during surgery, and finally develop a scientific and effective intraoperative anticoagulant therapy program.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.All patients undergoing hybird surgery.
排除标准
- •Poor general condition , severe primary disease, surgical contraindications
- •Patient or family refused surgery
- •Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
- •Combined with other hemorrhagic cerebrovascular disease
- •Combined with malignant brain tumor
- •Perinatal, Pregnancy
- •Patients unwilling to participate in the trial
研究组 & 干预措施
Standard dose group of Heparin Sodium
First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation.
干预措施: Heparin Sodium (Drug)
Low dose group of Heparin Sodium
infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.
干预措施: Heparin Sodium (Drug)
结局指标
主要结局
Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery
时间窗: From the beginning of surgery to 48 hours after surgery
Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.
次要结局
- Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery(From the beginning of surgery to 48 hours after surgery)
- Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery(From the beginning of surgery to 48 hours after surgery)
- Intraoperative blood loss(From the beginning of surgery to 48 hours after surgery)
研究者
Dr. Yong Cao
principal
Beijing Tiantan Hospital