Overview

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

Status:
Terminated
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Krankenhaus Barmherzige Schwestern Linz
Treatments:
Tissue Plasminogen Activator
Criteria
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)