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OpenTrials
Completed

NCT Number: NCT04846374

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.

Completed

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Key information

Conditions

Apheresis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PowerPort

Device

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

Primary outcomes

  1. 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.

  2. 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

  1. Change in Use of Tissue Plasminogen Activator

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2021
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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