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)