Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

Study Overview
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Brief Summary
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This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.

Detailed Description
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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.

Official Title
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A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Maintenance flushes at days 1-28 | |
| Group B<br>Maintenance flushes at days 29-56 | |
| Group C<br>Maintenance flushes at days 57+ | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 100 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ports, Catheters, Distal Valved Catheters, Maintenance Flush, subjects, routine maintenance flushes