A Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 试验地点
- 7
- 主要终点
- VTE incidence rate
研究概览
简要总结
Patients with Cushing disease was randomized to 2 groups. After surgery, the patients were managed with mechanical prevention or mechanical prevention plus anticoagulant drugs(LMWH followed by rivaroxaban), VTE was observed 24h, 5day, 4weeks and 12weeks after surgery.Bleeding events were also recorded.
详细描述
Cushing disease, caused by ACTH-secreting pituitary adenomas, can lead to serious complications with increased mortality. Minimally invasive surgery is currently the preferred treatment for the disease, allowing more than 80% of tumors to be completely removed. However, postoperative venous thrombosis (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) pose great threats to patients' safety. According to the literatures and the data from our center, up to 27% of the patients with Cushing's disease developed VTE after surgery. Due to the lacking of a randomized prospective study, there is no consensus or guideline on preventative anticoagulation protocols for postoperative management in patients with Cushing's disease. This is a prospective randomized control study on preventative anticoagulation in patients with Cushing's disease after transsphenoidal resection.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cushing's disease patient diagnosed and treated with transsphenoid surgery at study centers
排除标准
- •patients with thrombosis before surgery;
- •patients with cute bacterial endocarditis,
- •thrombocytopenia,
- •active peptic ulcer,
- •with contraindications to Rivaroxaban;
- •patients whose cranial MRA or CTA prompts abnormalities in intracranial blood vessels which may be at risk of intracranial hemorrhage;
- •patients with coagulation abnormalities suggesting a high risk of bleeding
研究组 & 干预措施
mechanical prevention
patients were managed with IPC
干预措施: IPC (Device)
mechanical plus anticoagulant drugs prevention
patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery
干预措施: LMWH/Rivaroxaban (Drug)
mechanical plus anticoagulant drugs prevention
patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery
干预措施: IPC (Device)
结局指标
主要结局
VTE incidence rate
时间窗: 12 weeks
DVT and PE incidence in 12 weeks after surgery
次要结局
- DVT incidence rate(12 weeks)
- PE incidence rate(12 weeks)
- Mortality(12 weeks)
- Symptomatic VTE incidence rate(12 weeks)
研究者
Zhaoyun Zhang
vice director of endocrine department
Huashan Hospital