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

Apheresis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04846374
• Other study ID #: 21-0287
• Status: Completed
• Start date: May 26, 2021
• Est. completion date: April 14, 2023

Study information

• Verified date: May 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apheresis

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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