Overview

Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes

Status:
Terminated
Trial end date:
2019-03-26
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
TriHealth Inc.
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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