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


N/A
21 Years
N/A
Open (Enrolling by invite only)
Both
Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

The primary endpoint is to compare 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).

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Michael McNamara, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alegent Health

Authority:

United States: Institutional Review Board

Study ID:

BAS-11-001

NCT ID:

NCT01586026

Start Date:

May 2012

Completion Date:

October 2012

Related Keywords:

  • Cancer
  • Ports
  • Catheters
  • Distal Valved Catheters
  • Maintenance Flush
  • subjects
  • routine maintenance flushes
  • Flushing

Name

Location

St. Luke's HospitalKansas City, Missouri  64111
Southeast Nebraska Cancer CenterLincoln, Nebraska  68510
Quincy Medical GroupQuincy, Illinois  62301
Willis Knighton Cancer CenterShreveport, Louisiana  71103
Alegent Research CenterOmaha, Nebraska  68154