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临床试验/NCT04351438
NCT04351438已完成不适用

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

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2012年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Percentage of patient complications during TPE

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received therapeutic plasma exchange at Children's of Alabama between 2012 and 2019

排除标准

  • Patients that received TPE with concomitant extra-corporeal membrane oxygenation

结局指标

主要结局

Percentage of patient complications during TPE

时间窗: complications during any TPE procedure (3 hours to 400 days)

patient-related complications during procedure

次要结局

  • Percentage of circuit-related complications during TPE(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Askenazi

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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