Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation

Overview

Despite its growing use across the world, and similar efficacy, filter-based therapeutic plasma exchange (TPE) continues to be used less often that centrifuge-based TPE. One of the reasons is that the patient and circuit complications of centrifuge-based TPE are familiar to the clinical team. There is little data on the patient and circuit complications of filter-based TPE (using the Prismaflex). Furthermore, there is a reluctance to use filter-based TPE because historically, most TPE programs have used citrate-regional anticoagulation, and there is a large gap in knowledge in the use of citrate regional anti-coagulation when using filter-based TPE.

Full Title of Study: “Prismaflex Therapeutic Plasma Exchange: Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Detailed Description

Studies that evaluate differences between filter-based vs. centrifuge based TPE are lacking. Heparin-based TPE is the most commonly used method of anti-coagulation when performing filter-based TPE. Citrate anticoagulation is FDA approved for use during TPE and its use is the gold-standard anti-coagulant method for TPE. However, citrate has not been studied rigorously in patients who are on filtration-based TPE on Prismaflex.

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.

Interventions

  • Device: Active Comparator: centrifuge TPE with citrate
    • Patients who received citrate-based anticoagulation with centrifuge TPE
  • Device: Active Comparator: Filter TPE with heparin
    • Patients who received heparin-based anticoagulation with filter TPE
  • Drug: Active comparator: Filter TPE with citrate
    • Patients who received citrate-based anticoagulation with filter TPE

Arms, Groups and Cohorts

  • Active Comparator: Centrifuge TPE with citrate
    • These participants were undergoing centrifuge TPE using citrate anticoagulant
  • Active Comparator: Filter TPE with heparin
    • These participants were undergoing filter TPE using filter-based heparin anticoagulant
  • Active Comparator: Filter TPE with citrate
    • These participants were undergoing filter TPE using filter-based citrate anticoagulant

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patient complications during TPE
    • Time Frame: complications during any TPE procedure (3 hours to 400 days)
    • patient-related complications during procedure

Secondary Measures

  • Percentage of circuit-related complications during TPE
    • Time Frame: 4 hours
    • circuit-related complications during procedure

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who received therapeutic plasma exchange at Children's of Alabama between 2012 and 2019

Exclusion Criteria

  • Patients that received TPE with concomitant extra-corporeal membrane oxygenation

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Askenazi, Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • David Askenazi, MD, Principal Investigator, University of Alabama at Birmingham

Citations Reporting on Results

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. Review.

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, Küllmar 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, Fernández Sarmiento J, Rojas Velasquez AM, González Chaparro LS, Gastelbondo Amaya R, Mulett Hoyos H, Tibaduiza D, Quintero Gómez 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. Erratum in: Pediatr Nephrol. 2017 Apr;32(4):719.

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. Review.

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.

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.

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