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

NCT04253756 | Completed Results FDA Device

• 1 other identifier: STU-2019-1363
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasma Exchange

Keywords

Plasma exchange; Photopheresis; Red blood Cell exchanges

Outcome Measures

Primary Outcomes (3)

• Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value

  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

  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

  Number of adverse events experienced by participants in each group is being compared here.

  12 months

Secondary Outcomes (1)

• Number of Participants Experiencing a Return Pressure >400 mmHg

  12 months

Study Arms (2)

18-gauge autogard catheter

NO INTERVENTION

Standard of care

20-gauge BD Nexiva Diffusics

EXPERIMENTAL

Intervention

Device: 20-gauge BD Nexiva Diffusics

Interventions

20-gauge BD Nexiva Diffusics DEVICE

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

20-gauge BD Nexiva Diffusics

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prisoners
• Persons under the age of 18 years
• Patient who are actively involved in chemotherapy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Becton, Dickinson and Company: collaborator

Study Sites (1)

Zale Lipshy Pavilion

Dallas, Texas, 75390, United States

Location

Related Publications (7)

• Spires SS, Rebeiro PF, Miller M, Koss K, Wright PW, Talbot TR. Medically Attended Catheter Complications Are Common in Patients With Outpatient Central Venous Catheters. Infect Control Hosp Epidemiol. 2018 Apr;39(4):439-444. doi: 10.1017/ice.2018.8. Epub 2018 Feb 15.

  PMID: 29444733 BACKGROUND

• Golestaneh L, Mokrzycki MH. Vascular access in therapeutic apheresis: update 2013. J Clin Apher. 2013 Feb;28(1):64-72. doi: 10.1002/jca.21267.

  PMID: 23420596 BACKGROUND

• Kalantari K. The choice of vascular access for therapeutic apheresis. J Clin Apher. 2012;27(3):153-9. doi: 10.1002/jca.21225. Epub 2012 Apr 26.

  PMID: 22535654 BACKGROUND

• Keller SC, Williams D, Rock C, Deol S, Trexler P, Cosgrove SE. A new frontier: Central line-associated bloodstream infection surveillance in home infusion therapy. Am J Infect Control. 2018 Dec;46(12):1419-1421. doi: 10.1016/j.ajic.2018.05.016. Epub 2018 Jun 13. No abstract available.

  PMID: 29908838 BACKGROUND

• Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.

  PMID: 28217433 BACKGROUND

• Shang J, Ma C, Poghosyan L, Dowding D, Stone P. The prevalence of infections and patient risk factors in home health care: a systematic review. Am J Infect Control. 2014 May;42(5):479-84. doi: 10.1016/j.ajic.2013.12.018. Epub 2014 Mar 20.

  PMID: 24656786 BACKGROUND

• Putensen D, Leverett D, Patel B, Rivera J. Is peripheral access for apheresis procedures underutilized in clinical practice?-A single centre experience. J Clin Apher. 2017 Dec;32(6):553-559. doi: 10.1002/jca.21508. Epub 2016 Sep 15.

  PMID: 27630072 BACKGROUND

Results Point of Contact

• Title: Sonja Stutzman, Research Programs Manager
• Organization: University of Texas Southwestern Medical Center

sonja.stutzman@utsouthwestern.edu

214-648-6719

Study Officials

• Tomas Armendariz, BSN

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: February 5, 2020
• Study Start: March 31, 2020
• Primary Completion: April 15, 2021
• Study Completion: May 24, 2021
• Last Updated: June 6, 2022
• Results First Posted: June 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)