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

Krankenhaus Barmherzige Schwestern Linz

Status and phase: Terminated; Phase 1

Conditions: Adjuvant Chemotherapy; Port-A-Cath; Solid Tumours

Treatments: Procedure: evaluation of PORT-A-CATH®; Drug: restoration of PORT-A-CATH® with Alteplase; Drug: blocking with Medunasal®-Heparinblock

Study type: Interventional

Funder types: Other

Identifiers

NCT02492477

TOP-TRIAL-2014-1.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

6 months

Experimental group

Description:

evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase

Treatment:

Procedure: evaluation of PORT-A-CATH®

Drug: blocking with Medunasal®-Heparinblock

Drug: restoration of PORT-A-CATH® with Alteplase

12 months

Experimental group

Description:

evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase

Treatment:

Procedure: evaluation of PORT-A-CATH®

Drug: blocking with Medunasal®-Heparinblock

Drug: restoration of PORT-A-CATH® with Alteplase