Analysis of TPE Treatments With multiFiltratePRO

Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.

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Key information

Conditions

Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Bavaria, Germany

About this study

The study is a retrospective, open, non-comparative, multi-centric PMCF study. The investigational device has CE approval. The investigation involves the retrospective collection of treatment data for the TPE treatment mode from the medical records. No further control treatments will be investigated in this one-arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the TPE mode of the multiFiltratePRO system.

The site will document the treatment data of patients with an indication for the TPE treatment who had been treated with the investigational devices under the TPE treatment mode between 2019 and October 2023 in chronological order.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Body weight ≥40kg irrespective of the age
Patients with indication for TPE treatment according to ASFA guideline
Patients have been treated with TPE between January 2019 and October 2023
Availability of at least 50% of the parameters to be documented for the patient

Exclusion criteria

Participation in an interventional clinical study during the retrospectively collected TPE treatment data
Previous documentation within this study
Simultaneous use of another filter for additional therapy form

Treatment and study plan

Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO

Device

Retrospective Data Analysis of TPE treatments with multiFiltratePRO

Primary outcomes

Total amount of exchange plasma (prescribed vs achieved exchange volume)

Time frame: through study completion, an average of 1 year

Statistical analysis is performed on retrospective data (Treatments between 2019 and October 2023). Primary goal of the study is to prove that the prescribed therapeutic plasma exchange rate during treatment was achieved in > 70% of treatments and therefore was in alignment with current guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Wammi

CONTACT

[email protected]

+49 6172 2686700

Manuela Stauss-Grabo, Dr.

CONTACT

[email protected]

+4915254601929

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Collaborators

X-act Cologne Clinical Research GmbH

Registry information

Acronym: TPEopt

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 22, 2024
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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