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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

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

Detailed Summary:

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.


Sponsor: C. R. Bard

Current 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.


Original Primary Outcome: The primary endpoint is to compare 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 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: C. R. Bard

Dates:
Date Received: April 25, 2012
Date Started: April 2012
Date Completion:
Last Updated: July 13, 2016
Last Verified: July 2016