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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Therapeutic Plasma Exchange, Anticoagulant Therapy

Intervention / Treatment
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* Device: Active Comparator: centrifuge TPE with citrate
* Device: Active Comparator: Filter TPE with heparin
* Drug: Active comparator: Filter TPE with citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Centrifuge TPE with citrate<br>These participants were undergoing centrifuge TPE using citrate anticoagulant | Device: Active Comparator: centrifuge TPE with citrate<br>* Patients who received citrate-based anticoagulation with centrifuge TPE<br>|
| Filter TPE with heparin<br>These participants were undergoing filter TPE using filter-based heparin anticoagulant | Device: Active Comparator: Filter TPE with heparin<br>* Patients who received heparin-based anticoagulation with filter TPE<br>|
| Filter TPE with citrate<br>These participants were undergoing filter TPE using filter-based citrate anticoagulant | Drug: Active comparator: Filter TPE with citrate<br>* Patients who received citrate-based anticoagulation with filter TPE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient complications during TPE | patient-related complications during procedure | complications during any TPE procedure (3 hours to 400 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of circuit-related complications during TPE | circuit-related complications during procedure | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complications, heparin, citrate, membrane, filter