The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- TEG values
研究概览
简要总结
The purpose of this study is to determine whether the use of different dose of LMWH compared with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of esophageal carcinoma and planned for esophagectomy
- •clinical diagnosis of lung carcinoma and planned for lung resection
- •general anesthesia combined with epidural anesthesia
排除标准
- •blood clotting disfunction before surgery
- •anticoagulating or antiplatelet history before surgery
- •low blood platelets count
- •hemorrhagic disease
- •cerebral hemorrhage
- •cerebral,spinal,ophthalmologic operation history
- •peptic ulcer
- •bleeding>400ml in operation
- •bleeding>100ml/h after operation
- •blood transfusion in or after operation
- •severe renal or liver disfunction
- •severe hypertension
研究组 & 干预措施
lung lmwh1
use LMWH once daily after lung resection
干预措施: Nadroparin Calcium (Drug)
lung lmwh2
use LMWH twice daily after lung resection
干预措施: Nadroparin Calcium (Drug)
lung Fondaparinux
use Fondaparinux once daily after lung resection
干预措施: Fondaparinux (Drug)
eso lmwh1
use LMWH once daily after esophagectomy
干预措施: Nadroparin Calcium (Drug)
eso lmwh2
use LMWH twice daily after esophagectomy
干预措施: Nadroparin Calcium (Drug)
eso Fondaparinux
use Fondaparinux once daily after esophagectomy
干预措施: Fondaparinux (Drug)
结局指标
主要结局
TEG values
时间窗: three days after surgery
1.5ml aterial blood sample will be obtained daily for TEG , and the vulues of TEG,such as R,K,Alpha angle,MA,G,CI ,will be measured
次要结局
- bleeding quantity of chest drainage(three days after surgery)
- incidence rate of deep venous thromboembolism（DVT)(after surgery up to 7 days)
- inhospital mortality(after surgery up to 28 days)
研究者
Ming Zhong
department of anesthesiology and surgical intensive care unit
Shanghai Zhongshan Hospital