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.
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
60
Retrospective Data Analysis of TPE treatments with multiFiltratePRO
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Charité-Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Total amount of exchange plasma (prescribed vs achieved exchange volume)
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.
Time frame: through study completion, an average of 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.