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NCT01586026 Clinical Trial

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

Cancer Clinical Trial

— DISTAL  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01586026
Other study ID # BAS-11-001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received April 25, 2012
Last updated April 27, 2012
Start date May 2012
Est. completion date October 2012

Study information
Verified date April 2012
Source C. R. Bard
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States St. Luke's Hospital Chesterfield Missouri
United States Southeast Nebraska Cancer Center Lincoln Nebraska
United States Alegent Research Center Omaha Nebraska
United States Quincy Medical Group Quincy Illinois
United States Willis Knighton Cancer Center Shreveport Louisiana

Sponsors (1)
Lead Sponsor Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 100 days Yes
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