CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
20-gauge BD Nexiva Diffusicsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04253756
NCT04253756N/ACompleted
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A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit

University of Texas Southwestern Medical Center·interventional·Posted Feb 5, 2020·Updated Jun 6, 2022

In Brief

A clinical study evaluating 20-gauge BD Nexiva Diffusics for Plasma Exchange. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasma Exchange
CountriesUnited States
CollaboratorsBecton, Dickinson and Company

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 5, 2020
Enrollment StartMar 31, 2020
Primary CompletionApr 15, 2021
Study CompletionMay 24, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.4 years ago

Interventions

20-gauge BD Nexiva Diffusicsdevice

The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.