Actively Recruiting

Age: 12Years - 99Years
All Genders
ID05004493

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

Led by Charles M Knudson · Updated on 2025-05-20

200

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with immune-mediated diseases who undergo plasma exchange (PLEX) procedures to remove harmful substances, often antibodies. This study aims to collect and preserve blood samples from these patients to analyze antibody levels and immune factors over time. The goal is to better understand how plasma exchange affects normal and harmful immune components in various patients. Participants will continue their usual plasma exchange treatments without changes from the study. The study groups include patients receiving plasma as a replacement fluid and those receiving saline or 5% albumin. Blood samples such as plasma, serum, and immune cells (PBMCs) will be collected at multiple points during and after treatment to facilitate current and future research. During the study, participants will provide blood samples and clinical data over the treatment course, typically lasting 1-2 weeks, to track antibody levels and immune factors. The study will also follow patients after plasma exchange completion to collect additional samples. This long-term collection helps researchers monitor immune changes and supports future studies. Participation involves no alteration to treatment plans and continues until the end of the plasma exchange course.

CONDITIONS

Brief Title

Biorepository and Registry for Plasma Exchange Patients

Who Can Participate

Age: 12Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing plasma exchange therapy
  • Age between 12 and 99 years
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - 1 to 2 weeks

Participants undergoing plasma exchange therapy are observed to assess changes in immune factors during treatment.

1 to 2 visits during treatment

Trial Site Locations

Total: 1 location

1

DeGowin blood Center

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

C

Charles Knudson, MD, PHD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

B cell activating factor (BAFF): Structure, functions, autoimmunity and clinical implications in Systemic Lupus Erythematosus (SLE).

Tamara Möckel, Fabio Basta, Julia Weinmann-Menke...

https://pubmed.ncbi.nlm.nih.gov/33333233