NCT05740150招募中不适用
The Efficacy of a Lock Solution Containing Taurolidine, Citrate and Heparin for the Prevention of Tunneled Central Line-associated Bloodstream Infections in Pediatric Oncology Patients, a Randomized Controlled, Mono-center Trial.
Princess Maxima Center for Pediatric Oncology2 个研究点 分布在 1 个国家目标入组 462 人开始时间: 2020年10月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 462
- 试验地点
- 2
- 主要终点
- Incidence of central line associated bloodstream infections
研究概览
简要总结
The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.
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
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 0 - <19 years
- •Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies)
- •Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology
- •Planned central venous access device insertion of >90 days
- •Written consent signed according to local law and regulations
- •Parents/guardians or patient are willing and able to comply with the trial procedure
排除标准
- •A previous central venous access device removed < 12 months ago.
- •Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks.
- •Primary immunological disorder
- •Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia.
- •Documented bacteremia in the period from 24h before catheter insertion until inclusion
结局指标
主要结局
Incidence of central line associated bloodstream infections
时间窗: From central venous access device insertion until the end of follow-up (maximum of 90 days).
次要结局
- Time to first central line associated bloodstream infection(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Incidence of symptomatic central venous thrombosis(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Central line associated bloodstream infection incidence per 1,000 central venous access device-days(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Incidence of and reasons for central venous access device-removal(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Incidence of bacteraemia(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Incidence of local infections(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
- Cultured microorganisms causing central line associated bloodstream infections(From central venous access device insertion until the end of follow-up (maximum of 90 days).)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
ATAPAC Study (TauroLock Activity in Adult Cancer Patients)Catheter-Related InfectionsNCT02279121Centre Hospitalier Régional Metz-Thionville162
已完成
4 期
Taurolidine in Haemodialysis Catheter Related BacteraemiaRenal DialysisCatheter-Related InfectionsNCT01243710Imperial College Healthcare NHS Trust27
已完成
不适用
Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1.35%) and 0.9% Saline As Prevention of Recurrent Catheter-related Bloodstream InfectionsCatheter Related Blood Stream InfectionsIntestinal FailureNCT06660641Rigshospitalet, Denmark61
招募中
不适用
Efficacy of Nerve Block Versus Botox in Chronic Migraine ManagementChronic MigraineChronic Migraine, HeadacheNCT06684249Zagazig University64
已完成
4 期
Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet ObstructionUrinary IncontinenceNCT00147654Pfizer's Upjohn has merged with Mylan to form Viatris Inc.830