TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients
Primary Purpose
Adjuvant Chemotherapy, Solid Tumours, Port-A-Cath
Status
Terminated
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
evaluation of PORT-A-CATH®
blocking with Medunasal®-Heparinblock
restoration of PORT-A-CATH® with Alteplase
Sponsored by
About this trial
This is an interventional health services research trial for Adjuvant Chemotherapy
Eligibility Criteria
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)
Sites / Locations
- Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
6 months
12 months
Arm Description
evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
Outcomes
Primary Outcome Measures
incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)
Secondary Outcome Measures
incidences of restoration of PORT-A-CATH® function by alteplase
rate of necessary PORT-A-CATH® removal
Full Information
NCT ID
NCT02492477
First Posted
June 29, 2015
Last Updated
August 19, 2018
Sponsor
Krankenhaus Barmherzige Schwestern Linz
1. Study Identification
Unique Protocol Identification Number
NCT02492477
Brief Title
TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
January 2016 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krankenhaus Barmherzige Schwestern Linz
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjuvant Chemotherapy, Solid Tumours, Port-A-Cath
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 months
Arm Type
Experimental
Arm Description
evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
Arm Title
12 months
Arm Type
Experimental
Arm Description
evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
Intervention Type
Procedure
Intervention Name(s)
evaluation of PORT-A-CATH®
Intervention Description
in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment
Intervention Type
Drug
Intervention Name(s)
blocking with Medunasal®-Heparinblock
Other Intervention Name(s)
heparinized 0,9% NaCl solution
Intervention Description
blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution
Intervention Type
Drug
Intervention Name(s)
restoration of PORT-A-CATH® with Alteplase
Other Intervention Name(s)
Actilyse®
Intervention Description
by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines
Primary Outcome Measure Information:
Title
incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)
Time Frame
6 or 12 months
Secondary Outcome Measure Information:
Title
incidences of restoration of PORT-A-CATH® function by alteplase
Time Frame
6 or 12 months
Title
rate of necessary PORT-A-CATH® removal
Time Frame
6 or 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Lafleur, OA Dr.
Organizational Affiliation
BHSL, Abt. für Gynäkologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4010
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients
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