Cancer Clinical Trial
— DISTALOfficial title:
A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters
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 |
This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.
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. |
Observational Model: Cohort, Time Perspective: Retrospective
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 |
Lead Sponsor | Collaborator |
---|---|
C. R. Bard |
United States,
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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