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

NCT04351438 | Completed FDA Drug FDA Device

• 1 other identifier: 300003769
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Therapeutic Plasma Exchange; Anticoagulant Therapy

Keywords

complications; heparin; citrate; membrane; filter

Outcome Measures

Primary Outcomes (1)

• Percentage of patient complications during TPE

  patient-related complications during procedure

  complications during any TPE procedure (3 hours to 400 days)

Secondary Outcomes (1)

• Percentage of circuit-related complications during TPE

  4 hours

Study Arms (3)

Centrifuge TPE with citrate

These participants were undergoing centrifuge TPE using citrate anticoagulant

Device: Active Comparator: centrifuge TPE with citrate

Filter TPE with heparin

These participants were undergoing filter TPE using filter-based heparin anticoagulant

Device: Active Comparator: Filter TPE with heparin

Filter TPE with citrate

These participants were undergoing filter TPE using filter-based citrate anticoagulant

Drug: Active comparator: Filter TPE with citrate

Interventions

Active Comparator: centrifuge TPE with citrate DEVICE

Patients who received citrate-based anticoagulation with centrifuge TPE

Centrifuge TPE with citrate

Active Comparator: Filter TPE with heparin DEVICE

Patients who received heparin-based anticoagulation with filter TPE

Filter TPE with heparin

Active comparator: Filter TPE with citrate DRUG

Patients who received citrate-based anticoagulation with filter TPE

Filter TPE with citrate

Eligibility Criteria

• Age: 0 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

retrospective database used to analyze subjects

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (8)

• 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.

  PMID: 23394211 RESULT

• 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.

  PMID: 30678706 RESULT

• 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.

  PMID: 30670518 RESULT

• 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.

  PMID: 30220281 RESULT

• 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.

  PMID: 27896442 RESULT

• 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.

  PMID: 22532037 RESULT

• 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.

  PMID: 17722047 RESULT

• 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.

  PMID: 28146331 RESULT

MeSH Terms

Interventions

Citric Acid

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• David Askenazi, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 17, 2020
• Study Start: January 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: February 4, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)