Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
NCT ID: NCT04351438
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
108 participants
OBSERVATIONAL
2012-01-01
2024-02-04
Brief Summary
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Detailed Description
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Providing citrate-based anticoagulation during TPE is challenging for several reasons. First, because calcium will bind to albumin, one must provide additional albumin in some way to prevent hypocalcemia. Second, when the replacement fluid is fresh frozen plasma (FFP), the clinician must account for a very large dose of citrate (which can be 3 times higher than the dose used to anti-coagulate whole blood) that is present in the FFP. Based on these principles, with clinical observations and experience using citrate-based continuous renal replacement therapy, this hospital developed a clinical protocol for use during filter-based TPE. This protocol has been in use since 2012 in the Renal Care Center at the Children's of Alabama.
As the use of filter-based TPE continue to rise, clinicians need evidence-based data to help them care for their patients. Although there are a few reports on the complication rates during centrifuge TPE, known, there are no published reports on the complication rate during filter-based TPE. A comparison of the complications rate between filter-based TPE and centrifuge TPE will help providers recognize the safety of filter-based TPE. There are no known regional citrate anticoagulation protocols for patients receiving filter-based TPE using Prismaflex. As the use of filter-based TPE continues to rise, there is a great need to fill this important knowledge gap. As more patients are cared in critical care arena, more clinicians will need evidence-based protocols for regional citrate anti-coagulation. This study will fill important gaps in knowledge that will improve the ability of clinical teams to provide filter-based TPE using Prismaflex.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Centrifuge TPE with citrate
These participants were undergoing centrifuge TPE using citrate anticoagulant
Active Comparator: centrifuge TPE with citrate
Patients who received citrate-based anticoagulation with centrifuge TPE
Filter TPE with heparin
These participants were undergoing filter TPE using filter-based heparin anticoagulant
Active Comparator: Filter TPE with heparin
Patients who received heparin-based anticoagulation with filter TPE
Filter TPE with citrate
These participants were undergoing filter TPE using filter-based citrate anticoagulant
Active comparator: Filter TPE with citrate
Patients who received citrate-based anticoagulation with filter TPE
Interventions
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Active Comparator: centrifuge TPE with citrate
Patients who received citrate-based anticoagulation with centrifuge TPE
Active Comparator: Filter TPE with heparin
Patients who received heparin-based anticoagulation with filter TPE
Active comparator: Filter TPE with citrate
Patients who received citrate-based anticoagulation with filter TPE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
0 Years
24 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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David Askenazi
Principal Investigator
Principal Investigators
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David Askenazi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama
Birmingham, Alabama, United States
Countries
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References
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Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
Zhang W, Bai M, Yu Y, Li L, Zhao L, Sun S, Chen X. Safety and efficacy of regional citrate anticoagulation for continuous renal replacement therapy in liver failure patients: a systematic review and meta-analysis. Crit Care. 2019 Jan 24;23(1):22. doi: 10.1186/s13054-019-2317-9.
Meersch M, Kullmar M, Wempe C, Kindgen-Milles D, Kluge S, Slowinski T, Marx G, Gerss J, Zarbock A; SepNet Critical Care Trials Group. Regional citrate versus systemic heparin anticoagulation for continuous renal replacement therapy in critically ill patients with acute kidney injury (RICH) trial: study protocol for a multicentre, randomised controlled trial. BMJ Open. 2019 Jan 21;9(1):e024411. doi: 10.1136/bmjopen-2018-024411.
Zhang C, Lin T, Zhang J, Liang H, Di Y, Li N, Gao J, Wang W, Liu S, Wang Z, Jiang H, Liu C. [Safety and efficacy of regional citrate anticoagulation in continuous renal replacement therapy in the presence of acute kidney injury after hepatectomy]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Aug;30(8):777-782. doi: 10.3760/cma.j.issn.2095-4352.2018.08.013. Chinese.
Rico MP, Fernandez Sarmiento J, Rojas Velasquez AM, Gonzalez Chaparro LS, Gastelbondo Amaya R, Mulett Hoyos H, Tibaduiza D, Quintero Gomez AM. Regional citrate anticoagulation for continuous renal replacement therapy in children. Pediatr Nephrol. 2017 Apr;32(4):703-711. doi: 10.1007/s00467-016-3544-9. Epub 2016 Nov 28.
Lee G, Arepally GM. Anticoagulation techniques in apheresis: from heparin to citrate and beyond. J Clin Apher. 2012;27(3):117-25. doi: 10.1002/jca.21222. Epub 2012 Apr 24.
Kankirawatana S, Huang ST, Marques MB. Continuous infusion of calcium gluconate in 5% albumin is safe and prevents most hypocalcemic reactions during therapeutic plasma exchange. J Clin Apher. 2007;22(5):265-9. doi: 10.1002/jca.20142.
Lemaire A, Parquet N, Galicier L, Boutboul D, Bertinchamp R, Malphettes M, Dumas G, Mariotte E, Peraldi MN, Souppart V, Schlemmer B, Azoulay E, Canet E. Plasma exchange in the intensive care unit: Technical aspects and complications. J Clin Apher. 2017 Dec;32(6):405-412. doi: 10.1002/jca.21529. Epub 2017 Feb 1.
Other Identifiers
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300003769
Identifier Type: -
Identifier Source: org_study_id
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