N/A
N=26
A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
Plasma Exchange
Bottom Line
View on ClinicalTrials.gov: NCT04253756 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value — 16.8; 17.3 g/dL — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 20-gauge BD Nexiva Diffusics (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value |
16.8; 17.3 | 0.87 |
| PRIMARY Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP |
90.1; 86.9 | 0.32 |
| PRIMARY Number of Adverse Events Experienced by Participants in Each Group |
0; 0 | — |
| SECONDARY Number of Participants Experiencing a Return Pressure >400 mmHg |
0; 0 | — |
Summary
This is a randomized pilot study of therapeutic apheresis procedures (TAP) using the current standard of care catheter (SOC) vs the BD Nexiva Diffusics Catheter. It is a single blinded, randomized study. Data will be used to refine and power a full randomized control trial. For this study, a sample of 33 encounters in each group (total of 66 encounters). The specific aim is to test the hypothesis that the 20-gauge BD Nexiva Diffusics Catheter provides the same efficacy and lower pain level with no increase in adverse events for patients undergoing apheresis treatments.
Eligibility Criteria
Inclusion Criteria
- Adult (≥18 years old)
- Speaks and reads English
- A patient of the Apheresis clinic at University of Texas Southwestern University Hospital and Clinics
- Scheduled to receive TAP (therapeutic plasma exchange, red blood cell exchange and extracorporeal Photopheresis) as standard of care
Exclusion Criteria
- Prisoners
- Persons under the age of 18 years
- Patient who are actively involved in chemotherapy
Data sourced from ClinicalTrials.gov (NCT04253756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.