TOP-TRIAL The Safety of Not Flushing the Non-used PORT-A-CATH® in Cancer Patients - a Prospective, Two-arm Phase I Trial, Pilot Trial

Krankenhaus Barmherzige Schwestern Linz1 个研究点分布在 1 个国家目标入组 4 人开始时间: 2016年1月最近更新: 2018年8月21日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 4
试验地点: 1
主要终点: incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The benefits and risks of flushing or not flushing the non-used PORT-A-CATH® in cancer patients and the time interval of eventual PORT-A-CATH® flushing are currently unknown. The manufacturers of PORT-A-CATH® recommend regular flushings every 4 weeks. In clinical practice, the intervals are usually at least three months. Regular flushing might lead to a decreased risk of PORT-A-CATH® thrombosis, but may also lead to an increased infection or thrombosis rate and patients discomfort. Therefore, this study investigates the safety of not flushing the PORT-A-CATH® for 6 or 12 months.

详细描述

Currently it is unknown if flushing a non-used PORT-A-CATH® every 4 weeks is a valid strategy to preserve its functioning. Even more, decision to keep the PORT-A-CATH® after completion of adjuvant therapy cannot be based on profound patient information as there exist hardly any data regarding PORT-A-CATH® related complications of non-used PORT-A-CATH®.

The proposed prospective, two arm trial aims to investigate if no flushing of a non-used PORT-A-CATH® over a period of one year has equal PORT-A-CATH® related complications compared to flushing the PORT-A-CATH® every 4 weeks.

The proposed trial also aims to examine the frequencies of PORT-A-CATH® related complications in non-used PORT-A-CATH®. The authors put up the hypothesis that there will be fewer port-a-cath related infections in the experimental arms compared to the infection rate mentioned in the literature up to 27 %, since the puncture of the PORT-A-CATH® and the administration of fluids are the main causes of infection.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Health Services Research
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: 否

入选标准

•Cancer patients in curative setting, with port a cath Implantation for systemic chemotherapy, including neo-adjuvant and adjuvant chemo-immunotherapy and supportive therapy (e.g. parenteral Nutrition)
•Completion of curative Treatment with port a cath indication, operation included, regardless of a non-intravenous (subcutaneous or oral) given therapy (endocrine therapy, chemo-immunotherapy, radiotherapy)
•patients with pectoral port a cath systems
•No port a cath associated complications during curative therapy such as investigated events: persistent malfunction, thrombosis, infection of the port-a-cath (to puncture the port a cath under X-ray control is allowed except it results in diangosis of persistent malfunction)
•No therapeutic anticoagulant therapy (phenprocoumon/Marcoumar®, heparin)
•No evidence of metastatic disease
•≥18 years
•Willing to participate

排除标准

•No signed informed consent
•Patients with port a cath systems other than pectoral port a cath systems (e.g. forearm port a cath System)
•Unable to attend control timepoints
•Use of the port-a-cath after the above defined curative treatment (within the investigational period)
•Willing to explant the port-a-cath
•Willing to become pregnant within one year after adjuvant treatment
•Patient with heparin-induced Thrombocytopenia (HIT)