A Phase 1 interventional study of evaluation of PORT-A-CATH® and blocking with Medunasal®-Heparinblock in Adjuvant Chemotherapy, Solid Tumours and Port-A-Cath, sponsored by Krankenhaus Barmherzige Schwestern Linz. Terminated at 1 site in Austria. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-08-21.
Sponsored by Krankenhaus Barmherzige Schwestern Linz · Phase 1, Interventional, and Health services research
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.
Exclusion Criteria:
evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
Procedure: evaluation of PORT-A-CATH® · Drug: blocking with Medunasal®-Heparinblock · Drug: restoration of PORT-A-CATH® with Alteplase
evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
Procedure: evaluation of PORT-A-CATH® · Drug: blocking with Medunasal®-Heparinblock · Drug: restoration of PORT-A-CATH® with Alteplase
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
Also known as: heparinized 0,9% NaCl solution
by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines
Also known as: Actilyse®
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
Plan to share: No
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Krankenhaus Barmherzige Schwestern Linz