Clinical Trial: TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Krankenhaus Barmherzige Schwestern Linz

Current Primary Outcome: incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection) [ Time Frame: 6 or 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Krankenhaus Barmherzige Schwestern Linz

Dates:
Date Received: June 29, 2015
Date Started: October 2015
Date Completion: June 2019
Last Updated: August 7, 2016
Last Verified: August 2016