Complication of CatheterPhase 2NCT01047644
Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.
A Phase 2 study testing Reduced port-flush schedule in people with Complication of Catheter, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks. It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complication of Catheter
- What is being tested?
- Reduced port-flush schedule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2017
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy)
- Without active disease
- Able to give informed consent
Who cannot join
- Minors, prisoners
- Previous PAC failure
- Disease recurrence
- Patients who had their PAC removed immediately following therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Extended Interval Port Flushes: A Phase II Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks.
It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.
Read the detailed description
This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1 year from enrollment of the last patient. Each enrolled patient will have his or her port flushed five times in 3 month intervals.
Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes, they will be followed for one year. At the end of the year patients will return to standard PAC flushes. If patients experience any PAC malfunction, it would be considered a PAC failure and the flushing will reverted back to the schedule recommended by the manufacturer.
- Conditions
- Complication of Catheter
- Being tested
- Reduced port-flush schedule
- Keywords
- port, catheter, infusion, flush, cleanse, chemotherapy
- Medical subject headings
- Blushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced port-flush scheduleOther
3-month port-flushing
| Study group | Role | What they receive |
|---|---|---|
| 3-month flushing schedule | Experimental | 3-month port-flushing schedule Receives: Other: Reduced port-flush schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to port complication
The short-term endpoint is time to port complication (EFP- event free port-complication). The long term end point will be time to port failure requiring removal of the port (OAP - overal port failure) and will be used to determine the efficacy of port flushes every 3 months.
Measured: Every 3 months for 1 year
Secondary outcomes (2)
Frequency and severity of toxicity
Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity.
Measured: every three months
Cost effectiveness
Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits.
Measured: every three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of CatheterStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Goetz Kloecker, University of Louisville
- Investigators
- Goetz H Kloecker, MD, Principal investigator, James Graham Brown Cancer Center, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047644
- Sponsor's protocol ID
- 09.0036
- Status last verified
- Jul 2021
- First submitted
- 11 Jan 2010
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.
PubMed 28084883
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Interval Port Flushes: A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT01047644
- Acronym / sponsor ID
- 09.0036
- Conditions
- Complication of Catheter
- Keywords
- port, catheter, infusion, flush, cleanse, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Mar 2009 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Jan 2010 (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 purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks.
It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.
Detailed description
This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1 year from enrollment of the last patient. Each enrolled patient will have his or her port flushed five times in 3 month intervals.
Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes, they will be followed for one year. At the end of the year patients will return to standard PAC flushes. If patients experience any PAC malfunction, it would be considered a PAC failure and the flushing will reverted back to the schedule recommended by the manufacturer.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3-month flushing schedule | Experimental | Other: Reduced port-flush schedule3-month port-flushing schedule |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy)
- Without active disease
- Able to give informed consent
Key exclusion criteria (4 listed)
- Minors, prisoners
- Previous PAC failure
- Disease recurrence
- Patients who had their PAC removed immediately following therapy.
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 |
|---|---|---|
| Reduced port-flush schedule3-month port-flushing | Other | 3-month flushing schedule |
Primary outcome
Time to port complication
Time frame: Every 3 months for 1 year
The short-term endpoint is time to port complication (EFP- event free port-complication). The long term end point will be time to port failure requiring removal of the port (OAP - overal port failure) and will be used to determine the efficacy of port flushes every 3 months.
2 secondary outcomes
Frequency and severity of toxicity
Time frame: every three months
Cost effectiveness
Time frame: every three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Derived from this study: PubMed 28084883Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.
- James Graham Brown Cancer Center, Louisville, KYLink provided by the sponsor.
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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.
Goetz H Kloecker, MD principal investigator
James Graham Brown Cancer Center, University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reduced port-flush schedule in people with Complication of Catheter, run by University of Louisville at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Jul 2021. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to port complication (time frame: Every 3 months for 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047644, which also lists 1 linked publication.
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 19 Jul 2021.