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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-11-30

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.

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

Maintenance flushes at days 1-28

No interventions assigned to this group

Group B

Maintenance flushes at days 29-56

No interventions assigned to this group

Group C

Maintenance flushes at days 57+

No interventions assigned to this group

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