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

Plasma Exchange Clinical Trial

— REPLACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253756
• Other study ID #: STU-2019-1363
• Status: Completed
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: May 24, 2021

Study information

• Verified date: May 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 24, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Plasma Exchange

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.

Locations

Country	Name	City	State
United States	Zale Lipshy Pavilion	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Becton, Dickinson and Company

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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, Mösges 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of Participants Experiencing a Return Pressure >400 mmHg	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