Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis

Completed

• Conditions: Apheresis

• Registration Number: NCT04846374
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Study Start: 2021-05-26
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Flow Rate	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	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 Outcome Measures

Name	Time	Method
Change in Use of Tissue Plasminogen Activator	1 year following new port configuration placement	The study will compare mean change in use of tissue plasminogen activator for pheresis sessions with the old system versus pheresis sessions with one of two new configurations.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States