A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
Condition: Plasma Exchange
Study type: Interventional

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.
    

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
    

Intervention name(s): 20-gauge BD Nexiva Diffusics
Intervention type(s): Device
Intervention description(s): The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasma exchange; Photopheresis; Red blood Cell exchanges