Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253756
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Becton, Dickinson and Company
Information provided by (Responsible Party):
Tomas Armendariz, University of Texas Southwestern Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Plasma Exchange Device: 20-gauge BD Nexiva Diffusics Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : August 27, 2021

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.




Primary Outcome Measures :
  1. The primary hypothesis is that the 20-gauge BD Nexiva Diffusics catheter has no increase in adverse events for patients undergoing therapeutic apheresis as compared to the standard of care when using plasma exchange. [ Time Frame: 12 to 18 months ]

    Number of Participants With Treatment-Related Adverse Events using 20-gauge BD Nexiva Diffusics for TAP procedures, as assessed by standard care minimum threshold of ratio of return and inlet rates.

    An adverse event will be determined if the high return pressure alarm is displayed by the exchange machine. When the alarm is triggered the operator will decrease the inlet speed to accommodate the return pressure. The minimum inlet threshold is determine by the procedure type. The minimum inlet threshold for plasma exchange 50ml/sec. If the minimum threshold has been reached, and the return pressure alarm is not resolved the catheter will be replaced with standard of care. The inlet rates average will be compared with historical inlet rate averages from the procedure.


  2. The primary hypothesis is that the 20-gauge BD Nexiva Diffusics catheter has no increase in adverse events for patients undergoing therapeutic apheresis as compared to the standard of care using red cell exchange. [ Time Frame: 12 to 18 months ]

    Number of Participants With Treatment-Related Adverse Events using 20-gauge BD Nexiva Diffusics for TAP procedures, as assessed by standard care minimum threshold of ratio of return and inlet rates.

    An adverse event will be determined if the high return pressure alarm is displayed by the exchange machine. When the alarm is triggered the operator will decrease the inlet speed to accommodate the return pressure. The minimum inlet threshold is determine by the procedure type. The minimum inlet threshold for red cell exchange 35ml/sec. If the minimum threshold has been reached and the return pressure alarm is not resolved the catheter will be replaced with standard of care. The inlet rates average will be compared with historical inlet rate averages from the procedure.


  3. The primary hypothesis is that the 20-gauge BD Nexiva Diffusics catheter has no increase in adverse events for patients undergoing therapeutic apheresis as compared to the standard of care when using photopheresis. [ Time Frame: 12 to 18 months ]

    Number of Participants With Treatment-Related Adverse Events using 20-gauge BD Nexiva Diffusics for TAP procedures, as assessed by standard care minimum threshold of ratio of return and inlet rates.

    An adverse event will be determined if the high return pressure alarm is displayed by the exchange machine. When the alarm is triggered the operator will decrease the inlet speed to accommodate the return pressure. The minimum inlet threshold is determine by the procedure type. The minimum inlet threshold for photopheresis is 20ml/sec. If the minimum threshold has been reached and the return pressure alarm is not resolved the catheter will be replaced with standard of care. The inlet rates average will be compared with historical inlet rate averages from the procedure.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253756


Contacts
Layout table for location contacts
Contact: Tomas Armendariz, BSN 2146454241 tomas.armendariz@utsouthwestern.edu
Contact: Sonja Stutzman, PhD 2146486719 sonja.stutzman@utsouthwestern.edu

Locations
Layout table for location information
United States, Texas
Zale Lipshy Pavilion Recruiting
Dallas, Texas, United States, 75390
Contact: Sonja Stutzman, PhD    214-648-6719    sonja.stutzman@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Becton, Dickinson and Company
Investigators
Layout table for investigator information
Principal Investigator: Tomas Armendariz, BSN UT Southwestern
Publications:

Layout table for additonal information
Responsible Party: Tomas Armendariz, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04253756    
Other Study ID Numbers: STU-2019-1363
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Tomas Armendariz, University of Texas Southwestern Medical Center:
Plasma exchange
Photopheresis
Red blood Cell exchanges