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

NCT04351438 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2024-02-08

No results posted yet for this study

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

Interventions

DEVICE

Active Comparator: centrifuge TPE with citrate

Patients who received citrate-based anticoagulation with centrifuge TPE

DEVICE

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

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David Askenazi, MD · University of Alabama at Birmingham

Eligibility

Min Age
0 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2019-12-31
Completion
2024-02-04
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04351438 on ClinicalTrials.gov