Plasma Exchange
Conditions
Keywords
Plasma exchange, Photopheresis, Red blood Cell exchanges
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.
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
Interventions
DEVICE20-gauge BD Nexiva Diffusics
The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
Sponsors
Becton, Dickinson and Company
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value | 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. |
| Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP | 12 months | Efficacy of assigned intervention is measured by comparing the time to complete the TAP in minutes and comparing the two treatment groups. |
| Number of Adverse Events Experienced by Participants in Each Group | 12 months | Number of adverse events experienced by participants in each group is being compared here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing a Return Pressure >400 mmHg | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This includes participants where one half was assigned to 18G catheter SOC (control) and the other half be assigned to 20G BD Nexiva Diffusics catheter (intervention). Each participant may participate a maximum of 10 times. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 18G Catheter SOC (Control) | Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value | 16.8 g/dL | Standard Deviation 9.64 |
| 20-gauge BD Nexiva Diffusics (Intervention) | Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value | 17.3 g/dL | Standard Deviation 12.4 |
p-value: 0.87ANOVA
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 18G Catheter SOC (Control) | Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP | 90.1 minutes | Standard Deviation 14.3 |
| 20-gauge BD Nexiva Diffusics (Intervention) | Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP | 86.9 minutes | Standard Deviation 13.2 |
p-value: 0.32ANOVA
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18G Catheter SOC (Control) | Number of Adverse Events Experienced by Participants in Each Group | 0 events |
| 20-gauge BD Nexiva Diffusics (Intervention) | Number of Adverse Events Experienced by Participants in Each Group | 0 events |
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18G Catheter SOC (Control) | Number of Participants Experiencing a Return Pressure >400 mmHg | 0 participants |
| 20-gauge BD Nexiva Diffusics (Intervention) | Number of Participants Experiencing a Return Pressure >400 mmHg | 0 participants |