Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery
试验速览
- 阶段
- 1 期
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- INR
研究概览
简要总结
Thromboembolism is an important perioperative complication in major thoracic surgery, even though current guidelines have recommended postoperative administration of heparin or LMWH for thromboprophylaxis for those high-risk patients, there are still many cases of thromboembolism. Therefore, as the guideline itself writes, the investigators believe the rational of dose and timing of heparin in thoracic surgery are still not well established. Therefore, the investigators aimed to conduct this randomized controlled study to explore the safety and efficacy of preoperative Administration of Heparin as Thromboprophylaxis in Major 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
- Single (Participant)
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
- •18-75 years old without any preoperative VTEs;
- •patients undergoing major thoracic surgery (including lobectomy, esophagectomy, and thymectomy).
排除标准
- •patients with coagulation disorders: preoperative international normalized ratio (INR) > 1.5, or blood platelet count < 50x10^9/L;
- •patients receiving any therapeutic anticoagulation preoperatively;
- •patients with severe renal or liver dysfunction.
研究组 & 干预措施
case group
start heparin sodium (5000IU, BID) upon admission, and continue until discharge
干预措施: Heparin (Drug)
control group
start heparin sodium (5000 IU,BID) from postoperative day 1, and continue until discharge
干预措施: Heparin (Drug)
结局指标
主要结局
INR
时间窗: on postoperative day 1 for both group
blood platlet count(/L)
时间窗: on postoperative day 1 for both group
chest tube drainage volume (ml)
时间窗: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy )
APTT (s)
时间窗: on postoperative day 1 for both group
intraoperative bleeding volume (ml)
时间窗: the bleeding volume (ml) during operation in the operation room for all patients
During the operation, the blood loss of each patient was collected and measured, and recorded by the investigators.
PT(s)
时间窗: on postoperative day 1 for both group
thromboembolism occurence rate (%)
时间窗: within 30 days after surgery
chest tube drainage duration (days)
时间窗: from postoperative day 1 to chest tube remove(usually on postoperative day 3 for lobectomy or thymectomy,on postoperative day 7 for esophagectomy )
次要结局
- PT(s)(rightly upon hospital admission day)
- APTT(s)(rightly upon hospital admission day)
- INR(rightly upon hospital admission day)
- blood platlet count(/L)(rightly upon hospital admission day)
研究者
Yi-Dan Lin
proffessor
West China Hospital