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

Sponsor
Krankenhaus Barmherzige Schwestern Linz (Other)
Overall Status
Terminated
CT.gov ID
NCT02492477
Collaborator
(none)
4
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: evaluation of PORT-A-CATH®
  • Drug: blocking with Medunasal®-Heparinblock
  • Drug: restoration of PORT-A-CATH® with Alteplase
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection) [6 or 12 months]

    Secondary Outcome Measures

    1. incidences of restoration of PORT-A-CATH® function by alteplase [6 or 12 months]

    2. rate of necessary PORT-A-CATH® removal [6 or 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H. Linz Upper Austria Austria 4010

    Sponsors and Collaborators

    • Krankenhaus Barmherzige Schwestern Linz

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Krankenhaus Barmherzige Schwestern Linz
    ClinicalTrials.gov Identifier:
    NCT02492477
    Other Study ID Numbers:
    • TOP-TRIAL-2014-1.2
    First Posted:
    Jul 8, 2015
    Last Update Posted:
    Aug 21, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Flushing
    Tissue Plasminogen Activator

    Study Results

    No Results Posted as of Aug 21, 2018