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NCT04253756 · ClinicalTrials.gov registry record · NA

A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit

A NA study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
NA
Development phase
26
Enrollment target

NCT04253756: Completed NA study, sponsored by University of Texas Southwestern Medical Center.

NCT04253756 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04253756, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
NA
Development phase
26 participants
Enrollment target

Study 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.

Primary Outcome

Efficacy of assigned intervention is measured by comparing the mean plasma hemoglobin values by group. Plasma hemoglobin test will be run on each patient to test for hemolysis (destruction of red blood cells which leads to the release of hemoglobin from the red blood cells into the blood plasma) which will be scored dichotomously as present or absent.

Interventions

  • DEVICE 20-gauge BD Nexiva Diffusics

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2020-03-31
Est. Completion 2021-05-24
Phase NA

What the finished NCT04253756 record still lists

NCT04253756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which 20-gauge BD Nexiva Diffusics is the first listed.

NCT04253756 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04253756 about?

NCT04253756 is a clinical study titled "A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit". 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 ...

What is the current status of trial NCT04253756?

This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2020-03-31. Estimated completion is 2021-05-24.

What interventions are being tested in trial NCT04253756?

The interventions under investigation include: 20-gauge BD Nexiva Diffusics (DEVICE).

Who is sponsoring clinical trial NCT04253756?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04253756's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04253756, the US trial registry maintained by the National Library of Medicine. NCT04253756 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.