Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- central venous catheter-related thrombosis
研究概览
简要总结
Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.
The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.
详细描述
Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.
At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
- •written informed consent
- •18 years or older
排除标准
- •the presence of a central venous catheter at admission
- •history of central venous catheter related thrombosis or infection
- •indication for anticoagulant treatment or prophylaxis
- •patients with totally implanted catheters
- •catheters impregnated with antimicrobial agents
结局指标
主要结局
central venous catheter-related thrombosis
时间窗: weekly from date of randomization until removal of the central venous catheter, up to one year
Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.
central venous catheter-related infections
时间窗: weekly from date of randomization untill the removal of the central venous catheter; up to one year
次要结局
- premature removal of the catheter(weekly from date of randomization untill removal of the central venous catheter; up to one year)
- failure to aspirate blood(weekly from date of randomization untill the removal of the central venous catheter; up to one year)
- hypocalcemic symptoms(weekly from dateof randomization untill the removal of the central venous catheter; up to one year)
- severe bleeding(weekly from date of randomization untill the removal of the central venous catheter; up to one year)