Symptoms and General Pathology

All Conditions

Flushing

Skin Manifestations

Michael McNamara, MD

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.

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

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

Study was terminated due to limited number of adverse events recorded.

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.

C. R. Bard

Adverse events were assessed separately for each flushing interval, and not for each participant

Group A

Group B

Group C

Demographics of 171 subjects that contributed to final data analysis

Combined Demographics

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Solid tumor

Hematologic

Cancer Type

Jugular

Subclavian

Unknown

Port Access Vein

Single Lumen

Dual Lumen

Port Configuration

7Fr.

8Fr.

9.5Fr.

#Fr. (French units) refers to the functional lumen/relative size of the catheter's diameter with smaller numbers indicating smaller diameters. Each increment of French sizing equals 0.33 mm.

Catheter Configuration

Post-infusional chemotherapy subjects that had Bard implanted ports with distally valved catheters.

Christopher DiMatteo

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).

Overall Study

Spots Global Cancer Trial Database for maintenance flush