Clinical trial NCT01586026: Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
Official title: A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Ports
Catheters
Distal Valved Catheters
Maintenance Flush
subjects
routine maintenance flushes
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 171
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects with an implanted Bard port with a distally valved catheter

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Shreveport
country: United States
facility: Willis Knighton Cancer Center
state: Louisiana
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Alegent Research Center
state: Nebraska
Study officials:
affiliation: Alegent Health
name: Michael McNamara, MD
role: PRINCIPAL_INVESTIGATOR
References: