Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.

Complication of Catheter Clinical Trial

Official title:

Extended Interval Port Flushes: A Phase II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047644
• Other study ID #: 09.0036
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: January 2017

Study information

• Verified date: July 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1 year from enrollment of the last patient. Each enrolled patient will have his or her port flushed five times in 3 month intervals. Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes, they will be followed for one year. At the end of the year patients will return to standard PAC flushes. If patients experience any PAC malfunction, it would be considered a PAC failure and the flushing will reverted back to the schedule recommended by the manufacturer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy)

2. Without active disease

3. Able to give informed consent

Exclusion Criteria:

1. Minors, prisoners

2. Previous PAC failure

3. Disease recurrence

4. Patients who had their PAC removed immediately following therapy.

Related Conditions & MeSH terms

• Complication of Catheter

Intervention

Other:
• Reduced port-flush schedule
3-month port-flushing

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency and severity of toxicity	Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity.	every three months
Secondary	Cost effectiveness	Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits.	every three months

External Links

•   James Graham Brown Cancer Center, Louisville, KY