Adjuvant ChemotherapyPhase 1NCT02492477
TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH® in Cancer Patients
A Phase 1 study testing evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock and restoration of PORT-A-CATH® with Alteplase in people with Adjuvant Chemotherapy and Solid Tumours, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adjuvant Chemotherapy, Solid Tumours, Port-A-Cath
- What is being tested?
- evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock and restoration of PORT-A-CATH® with Alteplase
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2016to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Krankenhaus der Barmherzigen Schwerstern Linz Betriebsges.m.b.H.
Linz, Upper Austria, 4010
About this study
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
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.
Read the 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.
- Conditions
- Adjuvant Chemotherapy, Solid Tumours, Port-A-Cath
- Being tested
- evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of PORT-A-CATH®Procedure or surgery
in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment
blocking with Medunasal®-HeparinblockDrug
Also called heparinized 0,9% NaCl solution
blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution
restoration of PORT-A-CATH® with AlteplaseDrug
Also called Actilyse®
by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines
| Study group | Role | What they receive |
|---|---|---|
| 6 months | Experimental | evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase Receives: Procedure: evaluation of PORT-A-CATH®; Drug: blocking with Medunasal®-Heparinblock; Drug: restoration of PORT-A-CATH® with Alteplase |
| 12 months | Experimental | evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase Receives: Procedure: evaluation of PORT-A-CATH®; Drug: blocking with Medunasal®-Heparinblock; Drug: restoration of PORT-A-CATH® with Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)
Measured: 6 or 12 months
Secondary outcomes (2)
incidences of restoration of PORT-A-CATH® function by alteplase
Measured: 6 or 12 months
rate of necessary PORT-A-CATH® removal
Measured: 6 or 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjuvant ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Lafleur, OA Dr., Principal investigator, BHSL, Abt. für Gynäkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492477
- Sponsor's protocol ID
- TOP-TRIAL-2014-1.2
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2015
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02492477
- Acronym / sponsor ID
- TOP-TRIAL-2014-1.2
- Conditions
- Adjuvant Chemotherapy, Solid Tumours, Port-A-Cath
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 months | Experimental | Procedure: evaluation of PORT-A-CATH®, Drug: blocking with Medunasal®-Heparinblock, Drug: restoration of PORT-A-CATH® with Alteplaseevaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase |
| 12 months | Experimental | Procedure: evaluation of PORT-A-CATH®, Drug: blocking with Medunasal®-Heparinblock, Drug: restoration of PORT-A-CATH® with Alteplaseevaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock, restoration of PORT-A-CATH® with Alteplase |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | 12 months, 6 months |
| blocking with Medunasal®-HeparinblockAlso: heparinized 0,9% NaCl solutionblocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution | Drug | 12 months, 6 months |
| restoration of PORT-A-CATH® with AlteplaseAlso: Actilyse®by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines | Drug | 12 months, 6 months |
Primary outcome
incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection)
Time frame: 6 or 12 months
2 secondary outcomes
incidences of restoration of PORT-A-CATH® function by alteplase
Time frame: 6 or 12 months
rate of necessary PORT-A-CATH® removal
Time frame: 6 or 12 months
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Lafleur, OA Dr. principal investigator
BHSL, Abt. für Gynäkologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing evaluation of PORT-A-CATH®, blocking with Medunasal®-Heparinblock and restoration of PORT-A-CATH® with Alteplase in people with Adjuvant Chemotherapy and Solid Tumours, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidences of PORT-A-CATH® related events (persistent malfunction, thrombosis, infection) (time frame: 6 or 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.