Trial Outcomes & Findings for A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit (NCT NCT04253756)

Last Updated: 2022-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

12 months

Results posted on

2022-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	26
Overall Study Procedure 1: 18 Guage	12
Overall Study Procedure 1: 20 Gauge	14
Overall Study Procedure 2: 18 Gauge	9
Overall Study Procedure 2: 20 Gauge	7
Overall Study Procedure 3: 18 Gauge	6
Overall Study Procedure 3: 20 Gauge	5
Overall Study Procedure 4: 18 Gauge	5
Overall Study Procedure 4: 20 Gauge	3
Overall Study Procedure 5: 18 Gauge	2
Overall Study Procedure 5: 20 Gauge	3
Overall Study Procedure 6: 18 Gauge	1
Overall Study Procedure 6: 20 Gauge	2
Overall Study Procedure 7: 18 Gauge	1
Overall Study Procedure 7: 20 Gauge	1
Overall Study Procedure 8: 18 Gauge	0
Overall Study Procedure 8: 20 Gauge	2
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=26 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.
Age, Continuous	45.2 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	18G Catheter SOC (Control) n=13 Participants The standard of care is an 18-gauge autogard catheter (control group)	20-gauge BD Nexiva Diffusics (Intervention) n=13 Participants 20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value	16.8 g/dL Standard Deviation 9.64	17.3 g/dL Standard Deviation 12.4

PRIMARY outcome

Timeframe: 12 months

Efficacy of assigned intervention is measured by comparing the time to complete the TAP in minutes and comparing the two treatment groups.

Outcome measures

Outcome measures
Measure	18G Catheter SOC (Control) n=13 Participants The standard of care is an 18-gauge autogard catheter (control group)	20-gauge BD Nexiva Diffusics (Intervention) n=13 Participants 20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
Efficacy of Assigned Intervention as Measured by the Amount of Time (Minutes) Required to Complete a TAP	90.1 minutes Standard Deviation 14.3	86.9 minutes Standard Deviation 13.2

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	18G Catheter SOC (Control) n=13 Participants The standard of care is an 18-gauge autogard catheter (control group)	20-gauge BD Nexiva Diffusics (Intervention) n=13 Participants 20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
Number of Adverse Events Experienced by Participants in Each Group	0 events	0 events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	18G Catheter SOC (Control) n=13 Participants The standard of care is an 18-gauge autogard catheter (control group)	20-gauge BD Nexiva Diffusics (Intervention) n=13 Participants 20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
Number of Participants Experiencing a Return Pressure >400 mmHg	0 participants	0 participants

Adverse Events

18-gauge Autogard Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

20-gauge BD Nexiva Diffusics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sonja Stutzman, Research Programs Manager

University of Texas Southwestern Medical Center

Phone: 214-648-6719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60