Solid Tumours Clinical Trial
Official title:
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
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.
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.
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