Multicentric, Randomized, Placebo Controlled and Double-blind Study to Evaluate the Efficacy and Safety of Antithrombotic Prophylaxis With Bemiparin (3,500 UI/Day) in Cancer Patients With a Central Venous Catheter (CVC)(BECAT)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 402
- 试验地点
- 19
- 主要终点
- Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to prevent CVC-related deep venous thrombosis (CVC-DVT)
详细描述
Venous thromboembolism (VTE) is a common complication in patients with cancer principally in association with central vein catheters (CVC). The clinical benefit of antithrombotic prophylaxis for CVC-related VTE in cancer patients remains unclear.The aim of this study is to evaluate the efficacy and safety of the administration of Bemiparin in cancer patients with a central venous catheter (CVC). This study is designed as a multicenter, randomized, double-blind, placebo-controlled study. On the day of CVC insertion, eligible patients are randomly assigned to receive subcutaneously either bemiparin (3,500 UI/day) or placebo by using preloaded syringes for 45 days.
The primary efficacy endpoint will be the combined incidence during the double blind treatment period of Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography)and subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
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
- Double
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
- •Patients over 18 years old of either sex who have given their informed consent to participate in the study.
- •Patients with a neoplastic process, with a CVC for the administration of anti-tumoral treatment or any other treatment related to the neoplastic process.
- •Patients with a platelet count above 30,000/mm
- •Patients with no hemorrhagic symptomatology at the time of their inclusion
排除标准
- •Patients with a history of clinically evident hemorrhagic episodes and/or with increased bleeding due to any other homeostatic alteration that contraindicates anticoagulant treatment and/or in the past two months have presented at least one of the following: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms).
- •Major surgery in the past two months.
- •Known hypersensitivity to LMWH, heparin or substances of porcine origin.
- •Patients with congenital or acquired bleeding diathesis.
- •Damage to or surgical interventions of the central nervous system, eyes and ears within the past 6 months.
- •Acute bacterial endocarditis or slow endocarditis.
- •Patients with a history of heparin-associated thrombocytopenia.
- •Patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic insufficiency (with values of AST and/or ALT > 5 times the normal value established by the reference range of the local hospital laboratory).
- •Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
- •Patients with suspected inability/or inability to comply with treatment and/or complete the study.
- •Patients who are participating in another clinical trial or have done so in the past 30 days.
- •Patients with a life expectancy less than 3 months.
- •Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
- •Patients on treatment with anticoagulants or who have been on treatment during the week previous to insert the CVC (including prophylaxis with heparin for hepatic veno-occlusive disease).
- •Patients diagnosed with acute leukemia or awaiting a transplant from hematopoietic progenitors during the 90 days of the study.
研究组 & 干预措施
Bemiparin
干预措施: Bemiparin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).
Subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 45±5 days after randomization.
次要结局
未报告次要终点