Clinical trial NCT04351438: Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
Official title: Prismaflex Therapeutic Plasma Exchange: Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Therapeutic Plasma Exchange
Anticoagulant Therapy
Keywords: complications
heparin
citrate
membrane
filter
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 108
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective database used to analyze subjects

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patient complications during TPE
timeFrame: complications during any TPE procedure (3 hours to 400 days)
Secondary outcomes:
measure: Percentage of circuit-related complications during TPE
timeFrame: 4 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David Askenazi, MD
role: PRINCIPAL_INVESTIGATOR
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