A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
N/A
21 Years
N/A
21 Years
N/A
Open (Enrolling by invite only)
Both
Cancer
Both
Cancer
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 Hospital | Kansas City, Missouri 64111 |
| Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
| Quincy Medical Group | Quincy, Illinois 62301 |
| Willis Knighton Cancer Center | Shreveport, Louisiana 71103 |
| Alegent Research Center | Omaha, Nebraska 68154 |
