Autoimmune Diseases
Conditions
Keywords
Therapeutical Plasma Exchange, ASFA Guideline
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.
Interventions
DEVICETherapeutic Plasma Exchange (TPE) option of multiFiltratePRO
Retrospective Data Analysis of TPE treatments with multiFiltratePRO
Sponsors
Fresenius Medical Care Deutschland GmbH
X-act Cologne Clinical Research GmbH
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORStefan Büttner, Dr. med.
Klinikum Aschaffenburg-Alzenau
Outcome results
None listed