Cancer
Conditions
Keywords
Ports, Catheters, Distal Valved Catheters, Maintenance Flush, subjects, routine maintenance flushes
Brief summary
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.
Interventions
None listed
Sponsors
C. R. Bard
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Subject is having port maintenance flushes/locks with citrate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combined Demographics Demographics of 171 subjects that contributed to final data analysis | 171 |
| Total | 171 |
Baseline characteristics
| Characteristic | Combined Demographics |
|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 12.3 |
| Cancer Type Hematologic | 29 participants |
| Cancer Type Solid tumor | 142 participants |
| Catheter Configuration 7Fr. | 0 participants |
| Catheter Configuration 8Fr. | 11 participants |
| Catheter Configuration 9.5Fr. | 0 participants |
| Catheter Configuration Unknown | 160 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Port Access Vein Jugular | 65 participants |
| Port Access Vein Subclavian | 102 participants |
| Port Access Vein Unknown | 4 participants |
| Port Configuration Dual Lumen | 1 participants |
| Port Configuration Single Lumen | 132 participants |
| Port Configuration Unknown | 38 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 160 Participants |
| Region of Enrollment United States | 171 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 350 | 1 / 414 | 2 / 271 |
| serious Total, serious adverse events | 0 / 350 | 0 / 414 | 0 / 271 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | 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 adverse events |
| Group B | 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). | 1 adverse events |
| 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). | 2 adverse events |