Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Stopped early · Phase 4
Conditions studied: Obstruction; Catheter, Infusion Catheter (Vascular), Catheter; Complications (Indwelling Catheter)
In brief
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.
Key facts
- Study ID
- NCT02923830
- Run by
- TriHealth Inc.
- People needed
- 28
- Starts
- 2016-04-01
- Expected to finish
- 2019-03-26
- Last updated by the study team
- 2019-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Able to read and understand English
- Has a BioFlo implanted port in place less than one (1) year
- Evidence of a patent BioFlo port catheter prior to enrollment in the study
- Is receiving active treatment (i.e., receiving a therapeutic drug) through the BioFlo implanted port
- Current treatment protocol projected to continue for a minimum of three (3) months
- Anticipates receiving care at the identified centers for 12 months following enrollment in the study
- Does not receive care of BioFlo implanted port at any other facility
You may not qualify if…
- Has documented heparin platelet antibody (i.e., could not be randomized to either group) or other allergy to heparin
- Receiving therapeutic dose of an anticoagulant (e.g.,warfarin, heparin, enoxaparin)
- Does not meet one or more of the inclusion criteria
Where it is running
- TriHealth Cancer Institute Good Samaritan Infusion Center at GSH — Cincinnati, Ohio, United States
- Ambulatory Treatment Center at Bethesda North TriHealth Hospital — Cincinnati, Ohio, United States
- TriHealth Cancer Institute Good Samaritan Infusion Center, Medicenter — Cincinnati, Ohio, United States
- TriHealth Cancer Institute Good Samaritan Infusion Center, Cheviot — Cincinnati, Ohio, United States
- TriHealth Cancer Institute Good Samaritan Infusion Center, Anderson — Cincinnati, Ohio, United States
- TriHealth Cancer Institute Good Samaritan Infusion Center Butler County — Hamilton, Ohio, United States
Full record on ClinicalTrials.gov
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