Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.
Extended Interval Port Flushes: A Phase II Clinical Trial
1 other identifier
interventional
87
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks. It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJuly 19, 2021
July 1, 2021
7.8 years
January 11, 2010
July 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to port complication
The short-term endpoint is time to port complication (EFP- event free port-complication). The long term end point will be time to port failure requiring removal of the port (OAP - overal port failure) and will be used to determine the efficacy of port flushes every 3 months.
Every 3 months for 1 year
Secondary Outcomes (2)
Frequency and severity of toxicity
every three months
Cost effectiveness
every three months
Study Arms (1)
3-month flushing schedule
EXPERIMENTAL3-month port-flushing schedule
Interventions
Eligibility Criteria
You may qualify if:
- All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy)
- Without active disease
- Able to give informed consent
You may not qualify if:
- Minors, prisoners
- Previous PAC failure
- Disease recurrence
- Patients who had their PAC removed immediately following therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Louisvillelead
- James Graham Brown Cancer Centercollaborator
Study Sites (1)
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Related Publications (1)
Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.
PMID: 28084883DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Goetz H Kloecker, MD
James Graham Brown Cancer Center, University of Louisville
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 13, 2010
Study Start
March 1, 2009
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
July 19, 2021
Record last verified: 2021-07