CancerDISTALNCT01586026
Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
An observational study of Cancer, run by C. R. Bard at 5 sites in United States.
Trial summary
This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- How many people
- 171 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2012to Nov 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects with an implanted Bard port with a distally valved catheter
Who may be able to join
- Male or female, age ≥ 21 years
- Subject has an implanted Bard port with a distally-valved catheter
- Subject has maintenance port flushes with heparin/heparinized saline or normal saline
- Subject is post infusional cancer therapy (solid tumor or hematologic)
- Subject has signed a HIPAA Authorization to use and disclose PHI
Who cannot join
- Subject is having port maintenance flushes/locks with citrate.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
St. Luke's Hospital
Chesterfield, Missouri, 63017
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68150
Alegent Research Center
Omaha, Nebraska, 68154
Quincy Medical Group
Quincy, Illinois, 62301
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
About this study
Official title: A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.
Read the detailed description
This study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have Bard totally implanted ports with distally-valved catheters.
This study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially >28 days for Bard ports with distally-valved catheters.
Reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. Subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port.
A financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. These costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. No financial information will be collected from subject medical records. All required information will be extrapolated from site staff.
- Conditions
- Cancer
- Keywords
- Ports, Catheters, Distal Valved Catheters, Maintenance Flush, subjects, routine maintenance flushes
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Maintenance flushes at days 1-28 | |
| Group B | Maintenance flushes at days 29-56 | |
| Group C | Maintenance flushes at days 57+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).
Subjects' maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Insufficient number of adverse events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McNamara, MD, Principal investigator, Alegent Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586026
- Sponsor's protocol ID
- BAS-11-001
- Acronym
- DISTAL
- Status last verified
- Jul 2016
- First submitted
- 25 Apr 2012
- Last updated
- 23 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Study was terminated due to limited number of adverse events recorded.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
- ClinicalTrials.gov ID
- NCT01586026
- Acronym / sponsor ID
- DISTAL / BAS-11-001
- Conditions
- Cancer
- Keywords
- Ports, Catheters, Distal Valved Catheters, Maintenance Flush, subjects, routine maintenance flushes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient number of adverse events
- Enrolment
- 171 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 23 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.
Detailed description
This study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have Bard totally implanted ports with distally-valved catheters.
This study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially >28 days for Bard ports with distally-valved catheters.
Reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. Subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port.
A financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. These costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. No financial information will be collected from subject medical records. All required information will be extrapolated from site staff.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Maintenance flushes at days 1-28 |
| Group B | – | –Maintenance flushes at days 29-56 |
| Group C | – | –Maintenance flushes at days 57+ |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects with an implanted Bard port with a distally valved catheter
Key inclusion criteria (5 listed)
- Male or female, age ≥ 21 years
- Subject has an implanted Bard port with a distally-valved catheter
- Subject has maintenance port flushes with heparin/heparinized saline or normal saline
- Subject is post infusional cancer therapy (solid tumor or hematologic)
- Subject has signed a HIPAA Authorization to use and disclose PHI
Key exclusion criteria (1 listed)
- Subject is having port maintenance flushes/locks with citrate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).
Time frame: 100 days
Subjects' maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Study was terminated due to limited number of adverse events recorded.
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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.
Michael McNamara, MD principal investigator
Alegent Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by C. R. Bard at 5 sites 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 5 inclusion and 1 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days). (time frame: 100 days). 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 23 Aug 2016.