Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Flow Rate
Study Overview
Brief Summary
Purpose: To describe a novel configuration of venous access for the performance of intermittent apheresis.
Participants: 20 participants at UNC who were referred for change from a vortex port to a powerflow port.
Procedures (methods): Placement of one of two configurations of the powerflow port and follow up visits between January 1, 2019 and December 31, 2023.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over the age of 18 years of age.
- •Referred for change from a vortex port to a powerflow port.
- •Previously placed or scheduled placement of one of two configurations of the PowerFlow port
Exclusion Criteria
- •Unable to read and understand English.
- •Unable to provide informed consent.
Outcomes
Primary Outcomes
Change in Flow Rate
Time Frame: 1 year following new port configuration placement
The study will compare mean change flow rate for pheresis sessions with the old system versus pheresis sessions with one of two new configurations by averaging the flow rate for up to 5 sessions using the new port configuration.
Change in Procedure Time
Time Frame: 1 year following new port configuration placement
The study will compare mean change in procedure time for pheresis sessions with the old system versus pheresis sessions with one of two new configurations.
Secondary Outcomes
- Change in Use of Tissue Plasminogen Activator(1 year following new port configuration placement)