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

Anticoagulant Therapy Clinical Trial

Official title:

Prismaflex Therapeutic Plasma Exchange: Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351438
• Other study ID #: 300003769
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: February 4, 2024

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 4, 2024
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant Therapy
• Therapeutic Plasma Exchange

Intervention

Device:
• 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

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

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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 De — View Citation

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 patie — View Citation

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 — View Citation

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]. Zhonghu — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patient complications during TPE	patient-related complications during procedure	complications during any TPE procedure (3 hours to 400 days)
Secondary	Percentage of circuit-related complications during TPE	circuit-related complications during procedure	4 hours