Analysis of TPE Treatments With multiFiltratePRO

Last updated: February 26, 2025
Sponsor: Fresenius Medical Care Deutschland GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO

Clinical Study ID

NCT06272084
CRRT-TPE-01-DE
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Participation in an interventional clinical study during the retrospectivelycollected TPE treatment data

  • Previous documentation within this study

  • Simultaneous use of another filter for additional therapy form

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO
Phase:
Study Start date:
May 22, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, Bavaria 63739
    Germany

    Active - Recruiting

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