Analysis of TPE Treatments With multiFiltratePRO

Recruiting

• Conditions: Autoimmune Diseases
• Interventions: Device: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO

• Registration Number: NCT06272084
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief 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.

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 Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-22
• Study Start: 2024-05-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TPE Treatments	Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO	Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline

Primary Outcome Measures

Name	Time	Method
Total amount of exchange plasma (prescribed vs achieved exchange volume)	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.

Trial Locations

Locations (1)

Klinikum Aschaffenburg-Alzenau; 🇩🇪 Aschaffenburg, Bavaria, Germany