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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04846374

Enrollment

Registered

2021-04-15

Start date

2021-05-26

Completion date

2023-04-14

Last updated

2023-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apheresis

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.

Interventions

DEVICEPowerPort

The study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026