Maintaining Patency in Implanted Port Catheters With Saline Only Flushes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TriHealth Inc.
- Enrollment
- 436
- Locations
- 16
- Primary Endpoint
- Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year
Study Overview
Brief Summary
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in 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.
Detailed Description
The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in 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. These complications include partial or complete obstruction, infection of the central line, and/or the onset of heparin induced thrombocytopenia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to read and understand English
- •Has an implanted port in place less than one (1) year
- •Evidence of a patent (unobstructed) port catheter prior to enrollment in the study
- •Is receiving active treatment (i.e., receiving a therapeutic drug through the 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 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 have a BioFlo port (heparinized port)
- •Does not meet one or more of the inclusion criteria
Outcomes
Primary Outcomes
Number of Participants With First Cathflo Administration for Occlusion (Blockage) Within 1 Year
Time Frame: baseline to 1 year
Number of Participants with First Cathflo administration for Occlusion (Blockage) within 1 year
Number of Participants With First Complete Occlusion Within 1 Year
Time Frame: baseline to 1 year
Number of participants who had a first complete occlusion (Blockage) within 1 year
Number of Participants With First Partial Occlusion Within 1 Year
Time Frame: baseline to 1 year
Number of Participants with First Partial Occlusion (Blockage) within 1 year
Secondary Outcomes
- Number of Participants With HIT Within 1 Year(baseline to 1 year)
- Number of Participants With First Complete or Partial Occlusion Within 1 Year(baseline to 1 year)
Investigators
Rachel Baker
Nurse Researcher
TriHealth Inc.