Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- VTE rate
研究概览
简要总结
Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality in women undergoing surgery for gynecologic malignancies. Although the benefit of thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic cancers has been well documented around the world, the evidence for Chinese women is rare. The investigators designed this prospective and randomized study to assess the benefit of pharmacologic prophylaxis for patients received surgical treatment for gynecologic malignancies in China.
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
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients of ovarian cancer, cervix cancer or endometrial cancer;
- •Age ≤ 70 years; female, Chinese women;
- •Initial treatment is surgery;
- •Laboratory tests: WBC ≥ 4×10(9)/L, NEU ≥ 2×10(9)/L, PLT ≥ 100×10(9)/L, serum bilirubin ≤ 1.5 times the upper limit of normal, transaminase ≤ 1.5 times the upper limit of normal, BUN, Cr ≤ normal
- •No prior pharmacologic prophylaxis;
- •Provide written informed consent.
排除标准
- •PLT ≤ 75×10(9)/L
- •Vascular injury
- •History of thrombosis
- •Liver and kidney dysfunction
- •Concurrently participating in other clinical trials
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
研究组 & 干预措施
s-LMWH
2125 I.U. subcutaneous injection for 5-10 days
干预措施: s-LMWH (Drug)
LMWH
4250 I.U. subcutaneous injection for 5-10 days
干预措施: LMWH (Drug)
Argatroban
20mg, injection for 5-10 days
干预措施: Argatroban (Drug)
结局指标
主要结局
VTE rate
时间窗: 30-days from the date of operation
次要结局
- Infection rate(30-days from the date of operation)
- Bleeding rate(30-days from the date of operation)
研究者
Ding Ma
Director of the department of Obstetrics and Gynecology, Tongji Hospital
Huazhong University of Science and Technology