Solid Tumours Clinical Trial
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
Verified date | August 2018 |
Source | Krankenhaus Barmherzige Schwestern Linz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Austria | Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H. | Linz | Upper Austria |
Lead Sponsor | Collaborator |
---|---|
Krankenhaus Barmherzige Schwestern Linz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection) | 6 or 12 months | ||
Secondary | incidences of restoration of PORT-A-CATH® function by alteplase | 6 or 12 months | ||
Secondary | rate of necessary PORT-A-CATH® removal | 6 or 12 months |
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