Plasma Exchange Clinical Trial
— REPLACEOfficial title:
A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
Verified date | May 2022 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Zale Lipshy Pavilion | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Becton, Dickinson and Company |
United States,
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
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 |
Status | Clinical Trial | Phase | |
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Not yet recruiting |
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