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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
4
in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment
blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution
by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines
Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.
Linz, Upper Austria, Austria
incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)
Time frame: 6 or 12 months
incidences of restoration of PORT-A-CATH® function by alteplase
Time frame: 6 or 12 months
rate of necessary PORT-A-CATH® removal
Time frame: 6 or 12 months
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