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

February 6, 2024 updated by: David Askenazi, University of Alabama at Birmingham

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

retrospective database used to analyze subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Centrifuge TPE with citrate
These participants were undergoing centrifuge TPE using citrate anticoagulant
Patients who received citrate-based anticoagulation with centrifuge TPE
Filter TPE with heparin
These participants were undergoing filter TPE using filter-based heparin anticoagulant
Patients who received heparin-based anticoagulation with filter TPE
Filter TPE with citrate
These participants were undergoing filter TPE using filter-based citrate anticoagulant
Patients who received citrate-based anticoagulation with filter TPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patient complications during TPE
Time Frame: complications during any TPE procedure (3 hours to 400 days)
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
Time Frame: 4 hours
circuit-related complications during procedure
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Askenazi, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

February 4, 2024

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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