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

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 Overview

• Status: Completed
• Conditions: Apheresis
• Intervention / Treatment: Device: PowerPort

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 20 adults will be enrolled to this study. The study subjects will be recruited from adults who are scheduled to receive or have received a PowerFlow™ Implantable Apheresis IV Port in Vascular Interventional Radiology for their clinical care.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PowerPort Subjects; This study will involve a chart review of patients at UNC who were referred for change from a vortex port to a powerflow port.	Device: PowerPort; The study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Flow Rate	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.	1 year following new port configuration placement
Change in Procedure Time	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.	1 year following new port configuration placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Use of Tissue Plasminogen Activator	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.	1 year following new port configuration placement

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Peter Bream, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-0287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: The investigator who proposes to use the data has received IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No