Analysis of TPE Treatments With multiFiltratePRO (TPEopt)

August 27, 2025 updated by: Fresenius Medical Care Deutschland GmbH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Aschaffenburg, Bavaria, Germany, 63739
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Universitatsklinikum Wurzburg
        • Contact:
    • State of Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TPE Treatments
Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline
Device: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO
Retrospective Data Analysis of TPE treatments with multiFiltratePRO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

X-act Cologne Clinical Research GmbH

Investigators

  • Principal Investigator: Stefan Büttner, Dr. med., Klinikum Aschaffenburg-Alzenau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRRT-TPE-01-DE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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