Trial record 16 of 400 for:    Louisville AND Brown

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047644
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : March 5, 2018
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Goetz Kloecker, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Complication of Catheter Other: Reduced port-flush schedule Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Extended Interval Port Flushes: A Phase II Clinical Trial
Study Start Date : March 2009
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: 3-month flushing schedule
3-month port-flushing schedule
Other: Reduced port-flush schedule
3-month port-flushing

Primary Outcome Measures :
  1. Time to port complication [ Time Frame: Every 3 months for 1 year ]
    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.

Secondary Outcome Measures :
  1. Frequency and severity of toxicity [ Time Frame: every three months ]
    Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity.

  2. Cost effectiveness [ Time Frame: every three months ]
    Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047644

United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
Principal Investigator: Goetz H Kloecker, MD James Graham Brown Cancer Center, University of Louisville

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Goetz Kloecker, Associate Professor, University of Louisville Identifier: NCT01047644     History of Changes
Other Study ID Numbers: 09.0036
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Goetz Kloecker, University of Louisville: