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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Adjuvant Chemotherapy, Solid Tumours, Port-A-Cath

Intervention / Treatment
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* Procedure: evaluation of PORT-A-CATH®
* Drug: blocking with Medunasal®-Heparinblock
* Drug: restoration of PORT-A-CATH® with Alteplase


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 months<br>evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase | Procedure: evaluation of PORT-A-CATH®<br>* in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment<br>Drug: blocking with Medunasal®-Heparinblock<br>* blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution<br>* Other names: heparinized 0,9% NaCl solution;Drug: restoration of PORT-A-CATH® with Alteplase<br>* by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines<br>* Other names: Actilyse®;|
| Experimental: 12 months<br>evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase | Procedure: evaluation of PORT-A-CATH®<br>* in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment<br>Drug: blocking with Medunasal®-Heparinblock<br>* blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution<br>* Other names: heparinized 0,9% NaCl solution;Drug: restoration of PORT-A-CATH® with Alteplase<br>* by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines<br>* Other names: Actilyse®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection) |  | 6 or 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidences of restoration of PORT-A-CATH® function by alteplase |  | 6 or 12 months | 
| rate of necessary PORT-A-CATH® removal |  | 6 or 12 months |