Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
研究概览
简要总结
We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease.
The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:
- Group A: heparin impregnated catheters
- Group B: low-dose unfractionated heparin (100 IU/kg/daily)
详细描述
Studies have shown that catheter-related infection may be due to fibrin deposition associated with catheters. Interventions designed to decrease fibrin deposition and thrombus formation have the potential to reduce catheter-related infections. Seven randomised studies have been performed to assess the safety and efficacy of heparin (either as an infusion or bonded to central venous catheter) on central venous catheter-related bloodstream infections. Although a meta-analysis of 4 studies looking at heparin either as an infusion or bonded to central venous catheter showed a strong trend for a reduction in catheter-related bloodstream infection with the use of heparin, these studies used variable definitions of catheter-related infections.
We have shown in a randomised study (in press), that low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:
- Group A: heparin impregnated catheters
- Group B: low-dose unfractionated heparin (100 IU/kg/daily)
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
- 4 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 4 and 60 years
- •Short term non-tunneled percutaneous central venous catheter
排除标准
- •Presence of a central venous catheter at admission
- •Major blood coagulation disorders (platelet count < 50 x 10^9, disseminated intravascular coagulation)
- •Absence of catheter-tip culture at the time of catheter removal
结局指标
主要结局
Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
Group A: heparin impregnated catheters
Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.
次要结局
- Analysis of variables that may be significant for the development of catheter-related bloodstream infection (catheter-related thrombosis; age; underlying disease; side of venous puncture; duration of catheterization)