Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
Condition: Therapeutic Plasma Exchange; Anticoagulant Therapy
Study type: Observational

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.
    

Intervention name(s): Active Comparator: centrifuge TPE with citrate; Active Comparator: Filter TPE with heparin; Active comparator: Filter TPE with citrate
Intervention type(s): Device; Device; Drug
Intervention description(s): Patients who received citrate-based anticoagulation with centrifuge TPE; Patients who received heparin-based anticoagulation with filter TPE; Patients who received citrate-based anticoagulation with filter TPE
Intervention MeSH terms: Heparin; Citric Acid; Sodium Citrate
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        retrospective database used to analyze subjects
      
Keywords: complications; heparin; citrate; membrane; filter