An observational study in Cancer, sponsored by C. R. Bard. Terminated at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-08-23.
Sponsored by C. R. Bard · Observational
This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.
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.
All subjects with an implanted Bard port with a distally valved catheter
Exclusion Criteria:
Maintenance flushes at days 1-28
Maintenance flushes at days 29-56
Maintenance flushes at days 57+
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.
Time frame: 100 days
| Milestone | Group A | Group B | Group C |
|---|---|---|---|
| Started | 350 | 414 | 271 |
| Completed | 350 | 414 | 271 |
| Not completed | 0 | 0 | 0 |
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.
| adverse events | Group A | Group B | Group C |
|---|---|---|---|
| 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). | 0 | 1 | 2 |
Collected over During retrospective review of subject records all defined adverse events were recorded from January 1, 2008 to date of chart review.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A | — | 0/350 (0%) | 0/350 (0%) |
| Group B | — | 0/414 (0%) | 1/414 (0.2%) |
| Group C | — | 0/271 (0%) | 2/271 (0.7%) |
| Event | Group A | Group B | Group C |
|---|---|---|---|
| Port/Catheter MalfunctionInjury, poisoning and procedural complications | 0/350 | 1/414 | 1/271 |
| Fractured CatheterGeneral disorders | 0/350 | 0/414 | 1/271 |
Post-infusional chemotherapy subjects that had Bard implanted ports with distally valved catheters.
| Age, Continuous(years) | Combined Demographics |
|---|---|
| Mean | 65.7 ± 12.3 |
| Sex: Female, Male(Participants) | Combined Demographics |
|---|---|
| Female | 111 |
| Male | 60 |
| Race (NIH/OMB)(Participants) | Combined Demographics |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 160 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Ethnicity (NIH/OMB)(Participants) | Combined Demographics |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 168 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Combined Demographics |
|---|---|
| United States | 171 |
| Cancer Type(participants) | Combined Demographics |
|---|---|
| Solid tumor | 142 |
| Hematologic | 29 |
| Port Access Vein(participants) | Combined Demographics |
|---|---|
| Jugular | 65 |
| Subclavian | 102 |
| Unknown | 4 |
| Port Configuration(participants) | Combined Demographics |
|---|---|
| Single Lumen | 132 |
| Dual Lumen | 1 |
| Unknown | 38 |
1 further baseline measures are reported on the registry.
Plan to share: No — Study was terminated due to limited number of adverse events recorded.
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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C. R. Bard