Adjuvant Chemotherapy, Port-A-Cath, Solid Tumours
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREevaluation of PORT-A-CATH®
in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment
DRUGblocking with Medunasal®-Heparinblock
blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution
DRUGrestoration of PORT-A-CATH® with Alteplase
by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines
Sponsors
Krankenhaus Barmherzige Schwestern Linz
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection) | 6 or 12 months |
Secondary
| Measure | Time frame |
|---|---|
| incidences of restoration of PORT-A-CATH® function by alteplase | 6 or 12 months |
| rate of necessary PORT-A-CATH® removal | 6 or 12 months |
Countries
Austria
Outcome results
None listed