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

NCT04846374 | Completed FDA Device

• 1 other identifier: 21-0287
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Apheresis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Use of Tissue Plasminogen Activator

  1 year following new port configuration placement

Study Arms (1)

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

Interventions

PowerPort DEVICE

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

PowerPort Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unable to read and understand English.
• Unable to provide informed consent.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Howlett MS, Hicks K, Park Y, Karafin MS, Bream PR Jr. Use of a novel configuration of ports for patients needing intermittent long-term apheresis. J Clin Apher. 2024 Aug;39(4):e22143. doi: 10.1002/jca.22143.

  PMID: 39105402 DERIVED

Study Officials

• Peter Bream, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: May 26, 2021
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• 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.

Locations

US (1)