NCT02492477TerminatedPhase 1

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

Krankenhaus Barmherzige Schwestern Linz1 site in 1 country4 target enrollmentStarted: January 2016Last updated: August 21, 2018

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Terminated
Sponsor
Enrollment: 4
Locations: 1
Primary Endpoint: incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Parallel
Primary Purpose: Health Services Research
Masking: None

Eligibility Criteria

Ages: 18 Years to 90 Years (Adult, Older Adult)
Sex: All
Accepts 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)