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

May 11, 2022 updated by: Tomas Armendariz, University of Texas Southwestern Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

TAP treats a wide range of disease processes and, in all cases, requires inlet and return venous access to perform the procedure. The goal of TAP is to return the patient to baseline and maintain independence and function. A larger needle (18 gauge) can cause more discomfort to the patient as well as additional scarring. A smaller needle may present less discomfort and scarring to the patient. The goal in the outpatient clinic is to minimize disruption to the patient's routine and help the patient maintain normal activities of daily living.

To accomplish these goals, the outpatient clinic is open Monday thru Friday offering 4 different appointment times. All patients that are referred to the clinic for TAP, first receive a vein evaluation to see if the patient is a candidate for peripheral IV therapy. At the clinic, approximately 68% of the patients TAP's are performed peripherally. This eliminates the risk of a central line infection and any alteration in activities of daily living, such as bathing(Kramer, 2016), (Shang, Ma, Poghosyan, Dowding, & Stone, 2014),(Keller et al., 2018; McDiarmid, 2015).

The hypothesis, is that the 20-gauge BD Nexiva Diffusics catheter provides the same efficacy as current practice with no increase in adverse events for patients undergoing therapeutic apheresis. The results from the study will be significant because if the 20 gauge needle is equally effective for TAP, it can increase the number of patients that would be candidates for peripheral therapy. Therefore, decreasing the need for central venous access, which place the patient at an increased risk of infection. The study is a comparison of 2 types of infusion catheters. The standard of care is an 18-gauge autogard catheter (control group) which will be compared to the 20-gauge BD Nexiva Diffusics (intervention).

P - patients who require therapeutic apheresis procedures (TAP) I - use of 20 guage (20G) BD diffusics catheter during apheresis C - use of 18 G standard of care IV catheter during apheresis O - no difference in efficacy and no increase in safety events

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Zale Lipshy Pavilion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 18-gauge autogard catheter
Standard of care
EXPERIMENTAL: 20-gauge BD Nexiva Diffusics
Intervention
Device: 20-gauge BD Nexiva Diffusics
The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value
Time Frame: 12 months
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.
12 months
Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP
Time Frame: 12 months
Efficacy of assigned intervention is measured by comparing the time to complete the TAP in minutes and comparing the two treatment groups.
12 months
Number of Adverse Events Experienced by Participants in Each Group
Time Frame: 12 months
Number of adverse events experienced by participants in each group is being compared here.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing a Return Pressure >400 mmHg
Time Frame: 12 months
Number of participants experiencing a return pressure >400 mmHg when the return catheter occupies <45% of the inner-lumen diameter is being measured. The suggested standard is that a catheter occupies < 45% of the inner-lumen diameter (measured with ultrasound). Return pressures >400 mm Hg are considered problematic.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Becton, Dickinson and Company

Investigators

  • Principal Investigator: Tomas Armendariz, BSN, UT Southwestern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 31, 2020

Primary Completion (ACTUAL)

April 15, 2021

Study Completion (ACTUAL)

May 24, 2021

Study Registration Dates

First Submitted

January 25, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU-2019-1363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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