Plasma ExchangeREPLACENCT04253756
A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
A study testing 20-gauge BD Nexiva Diffusics in people with Plasma Exchange, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Plasma Exchange
- What is being tested?
- 20-gauge BD Nexiva Diffusics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2020to 24 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prisoners
- Persons under the age of 18 years
- Patient who are actively involved in chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Plasma Exchange
- Being tested
- 20-gauge BD Nexiva Diffusics
- Keywords
- Plasma exchange, Photopheresis, Red blood Cell exchanges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-gauge BD Nexiva DiffusicsDevice
The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
| Study group | Role | What they receive |
|---|---|---|
| 18-gauge autogard catheter | No intervention | Standard of care |
| 20-gauge BD Nexiva Diffusics | Experimental | Intervention Receives: Device: 20-gauge BD Nexiva Diffusics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start31 Mar 2020
- Primary completion15 Apr 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Plasma ExchangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Responsible party
- Principal investigator, Tomas Armendariz, University of Texas Southwestern Medical Center
- Investigators
- Tomas Armendariz, BSN, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253756
- Sponsor's protocol ID
- STU-2019-1363
- Acronym
- REPLACE
- Status last verified
- May 2022
- First submitted
- 25 Jan 2020
- Last updated
- 6 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29444733Golestaneh L, Mokrzycki MH. Vascular access in therapeutic apheresis: update 2013. J Clin Apher. 2013 Feb;28(1):64-72. doi: 10.1002/jca.21267.
PubMed 23420596Kalantari 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.
PubMed 22535654Keller 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.
PubMed 29908838Klimek 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.
PubMed 28217433Shang 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.
PubMed 24656786Putensen 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.
PubMed 27630072
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
- ClinicalTrials.gov ID
- NCT04253756
- Acronym / sponsor ID
- REPLACE / STU-2019-1363
- Conditions
- Plasma Exchange
- Keywords
- Plasma exchange, Photopheresis, Red blood Cell exchanges
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Becton, Dickinson and Company
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 6 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18-gauge autogard catheter | No intervention | –Standard of care |
| 20-gauge BD Nexiva Diffusics | Experimental | Device: 20-gauge BD Nexiva DiffusicsIntervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Prisoners
- Persons under the age of 18 years
- Patient who are actively involved in chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20-gauge BD Nexiva DiffusicsThe BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made. | Device | 20-gauge BD Nexiva Diffusics |
Primary outcome
Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value
Time frame: 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
Time frame: 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
Time frame: 12 months
Number of adverse events experienced by participants in each group is being compared here.
1 secondary outcome
Number of Participants Experiencing a Return Pressure >400 mmHg
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29444733Spires 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.
- Background: PubMed 23420596Golestaneh L, Mokrzycki MH. Vascular access in therapeutic apheresis: update 2013. J Clin Apher. 2013 Feb;28(1):64-72. doi: 10.1002/jca.21267.
- Background: PubMed 22535654Kalantari 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.
- Background: PubMed 29908838Keller 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.
- Background: PubMed 28217433Klimek 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.
- Background: PubMed 24656786Shang 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.
- Background: PubMed 27630072Putensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Armendariz, BSN principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20-gauge BD Nexiva Diffusics in people with Plasma Exchange, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Assigned Intervention as Measured by Plasma Hemoglobin Value (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253756, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.