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

August 19, 2018 updated by: Krankenhaus Barmherzige Schwestern Linz

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Barmherzige Schwestern Linz

Investigators

  • Principal Investigator: Judith Lafleur, OA Dr., BHSL, Abt. für Gynäkologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

July 4, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 19, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOP-TRIAL-2014-1.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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