NCT03282643已完成1 期
Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture
Capital Medical University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2016年2月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Incidence rate of deep venous thrombosis
研究概览
简要总结
The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 85
- •Histologically or cytologically confirmed advanced or metastatic solid tumors
- •Patients will be received femoral venepuncture for apheresis by cell separator, which is the necessary process to perform following adoptive cell immunotherapy.
- •Estimated life expectancy > 3 months
- •Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5 (unless patient is receiving warfarin in which case PT-INR must be <3), PTT <1.5X ULN
- •Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
排除标准
- •known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
- •Platelet count < 50 000 G/L
- •Active bleeding
- •Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
- •Patients with obstructive jaundice
- •Patients with Spleen hyperfunction
- •Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
- •Pregnant or breast-feeding women，or lack of effective contraceptive treatment for women of childbearing age.;
研究组 & 干预措施
Rivaroxaban 10mg daily
Experimental
orally, 10 mg once daily for day1 and day 2 after femoral venepuncture
干预措施: Rivaroxaban 10 MG (Drug)
Rivaroxaban 20mg daily
Experimental
orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture
干预措施: Rivaroxaban 20 MG (Drug)
Low-molecular-weight heparin
Active Comparator
subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)
干预措施: Low-molecular-weight heparin (Drug)
结局指标
主要结局
Incidence rate of deep venous thrombosis
时间窗: 4 weeks
the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](4 weeks)
研究者
Jun Ren MD, PhD
Dean & Director
Capital Medical University
研究点 (1)
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