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

Terminated

• Conditions: Cancer

• Registration Number: NCT01586026
• Lead Sponsor: C. R. Bard

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2014-07-10
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-13
• Last Update Submitted: 2016-07-13
• Results First Posted: 2016-08-23
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 171

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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.

Trial Locations

Locations (5)

St. Luke's Hospital; 🇺🇸 Chesterfield, Missouri, United States

Willis Knighton Cancer Center; 🇺🇸 Shreveport, Louisiana, United States

Southeast Nebraska Cancer Center; 🇺🇸 Lincoln, Nebraska, United States

Quincy Medical Group; 🇺🇸 Quincy, Illinois, United States

Alegent Research Center; 🇺🇸 Omaha, Nebraska, United States