Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Incidence of asymptomatic Deep Venous Thrombosis (DVT)
研究概览
简要总结
Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations.
The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis.
Study followup duration is up to 30 days post surgical procedure.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years
- •Gastrointestinal (GI) Cancer
- •Elective or emergency surgery
- •Preventive administration of enoxaparin sodium
排除标准
- •Patients participating in another study
- •Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure
- •Renal failure with creatinine clearance <30 ml / min
- •Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion
- •Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method
- •Anticoagulant use in the 3 months prior to inclusion
- •Patients with known haemostatic disorder
- •Patients not consenting to participate in the study, or not capable of understanding its objectives
研究组 & 干预措施
ENOXA® group
Patients under ENOXA® 4000 IU according to randomization:
- Administer ENOXA® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion
- Start injections 12 hours after the surgical procedure
- Administer ENOXA® subcutaneously
- The administration of ENOXA® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines
干预措施: Enoxaparin 4000 IU (Drug)
LOVENOX® group
Patients under LOVENOX® 4000 IU according to randomization:
- Administer LOVENOX® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion
- Start injections 12 hours after the surgical procedure
- Administer LOVENOX® subcutaneously
- The administration of LOVENOX® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines
干预措施: Enoxaparin 4000 IU (Drug)
结局指标
主要结局
Incidence of asymptomatic Deep Venous Thrombosis (DVT)
时间窗: 7 - 10 days postoperative
To compare the incidence of asymptomatic DVT, assessed by Echo Doppler of the lower limbs, between the two study treatment arms
次要结局
- Incidence of symptomatic thromboembolic events(30 days postoperative)
- Number of adverse events(30 days postoperative)
- Incidence of both Enoxaparin formulations immunogenicity(0 -10 days postoperative)