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临床试验/NCT05004493
NCT05004493招募中不适用

Assessment of Changes in Normal and Pathological Immune Factors in Patients Undergoing Plasma Exchange

Charles M Knudson1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
IgG and IgM antibody levels

研究概览

简要总结

Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered within the standard of care for these patients and are covered by insurance. This study will not influence the treatment plan for subjects who participate in this study. The goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, PBMCs) for current and future studies. Any patient undergoing plasma exchange procedures will be eligible for the study. Patients or the legally authorized representative (LAR) will be consented for the study as soon as feasible after the are referred to DeGowin for plasma exchange. The immediate objective of the study is to examine antibody levels (IgG/IgM) and BAFF levels in the blood of these patients over the course of the plasma exchange treatments. Specimens and clinical data will be collected such that other immune factors that may regulate B cell survival, proliferation and antibody secretion can be studied. Another goal of the study is to isolate and cryopreserve PBMCs at different points during the patient's treatment. This would allow the study of immune cells that may mediate these diseases. The study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. The collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

IgG and IgM antibody levels

时间窗: Levels over the course of treatment will be compared. Typically 1-2 weeks.

The effect of replacement fluids on IgG and IgM antibody levels will be examined.

次要结局

未报告次要终点

研究者

发起方
Charles M Knudson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Charles M Knudson

Clinical Professor

University of Iowa

研究点 (1)

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