Actively Recruiting
Retrospective Analysis of Therapeutic Plasma Exchange Treatments Using the multiFiltratePRO Device Evaluation of Performance in Autoimmune Disease Patients Treated Between 2019 and 2023
Led by Fresenius Medical Care Deutschland GmbH · Updated on 2025-08-28
60
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of the therapeutic plasma exchange TPE mode of the multiFiltratePRO device, which is used for extracorporeal blood purification treatments. This retrospective, open, non-comparative, multi-center study collects past treatment data to understand how well the TPE mode exchanges plasma from whole blood in patients with autoimmune diseases. The study aims to contribute real-world evidence on the devices performance in daily clinical practice. The study involves gathering data from medical records of patients who received TPE treatment using the multiFiltratePRO device between January 2019 and October 2023. There is no comparison to other treatments, and the study focuses on analyzing TPE treatments according to the American Society for Apheresis ASFA guidelines. The investigational device has CE approval for use in these treatments. Participants will have their treatment data reviewed, including the total amount of plasma exchanged compared to what was prescribed. The study will collect at least 50% of the relevant treatment parameters from patient records. No new treatments or interventions will be administered, and patient safety monitoring or follow-up beyond data collection is not part of this study. The study is expected to be completed by December 2025.
CONDITIONS
Brief Title
Analysis of TPE Treatments With multiFiltratePRO
Research Team
M
Manuela Stauss-Grabo, Dr.
A
Anna Wammi
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