Analysis of TPE Treatments With multiFiltratePRO
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autoimmune Diseases
- Sponsor
- Fresenius Medical Care Deutschland GmbH
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Total amount of exchange plasma (prescribed vs achieved exchange volume)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
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.