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

C. R. Bard

Status

Terminated

Conditions

Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT01586026

BAS-11-001

Details and patient eligibility

About

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

Full 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.

Enrollment

171 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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