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临床试验/NCT02405728
NCT02405728已完成不适用

Vascular Access in Hematological Patients - PICC Versus CVC in a Phase IV Randomized Controlled Trial

Federico II University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Catheter-related bloodstream infections

研究概览

简要总结

The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and cost-effectiveness compared with centrally inserted central catheters (CICCs).

详细描述

The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and costeffectiveness compared with centrally inserted central catheters (CICCs). Despite these benefits, PICCs are associated with deep vein thrombosis of the arm and pulmonary embolism. These complications, which are often called venous thromboembolism, are important because they not only complicate and interrupt treatment, but also increase cost, morbidity and mortality. Despite this effect, the burden and risk of PICC-related venous thromboembolism is uncertain and clinicians have scarce evidence on which to base choice of vascular access. Evidence to choose one vascular access over the other is lacking in literature, in particular for patients affected by haematological malignancies, in which chemotherapy is more likely to cause myelosuppression, with a major risk of bloodstream infections. Furthermore, the precise incidence and the risk of PICC-related venous thromboembolism relative to that of other CICCs is unknown. An understanding of this risk in the context of growing PICC use is an important cost and patients safety questions. Up to now, no systematic review has been done to investigate these questions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 yrs
  • Newly diagnosed AML
  • Suspected survival > 4 weeks
  • Need of central venous access >4 weeks

排除标准

  • Ongoing uncontrolled systemic infection
  • Presence of significant thrombosis/stenosis in arm or central veins
  • Diagnosis of another cancer within 12 months before AML onset
  • any evidence of clinical conditions indicating unability to receive intent-to- cure chemotherapy
  • Unability to communicate and/or to sign informed consent

研究组 & 干预措施

Peripherally inserted central catheters

Experimental

Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs

干预措施: Peripherally inserted central catheters (PICCs) (Device)

Centrally inserted central catheter

Active Comparator

Centrally inserted central catheter (CICCs) - New vascular access, with the aim to reduce the complications - Randomization between CICCs and PICCs

干预措施: Centrally inserted central catheters (CICCs) (Device)

结局指标

主要结局

Catheter-related bloodstream infections

时间窗: 1 year

1. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.

次要结局

  • Other complications(1 year)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Picardi

Prof

Federico II University

研究点 (1)

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