Analysis of TPE Treatments With multiFiltratePRO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO.
- Who it may be relevant to
- Registry conditions: Autoimmune Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO
Retrospective Data Analysis of TPE treatments with multiFiltratePRO
Primary outcome measures
- Total amount of exchange plasma (prescribed vs achieved exchange volume) [Time frame: through study completion, an average of 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 3 centers
- Klinikum Aschaffenburg-Alzenau — Aschaffenburg
- Universitätsklinikum Würzburg — Würzburg
- Charité-Universitätsmedizin Berlin — Berlin
Identifiers
NCT: NCT06272084 · CRRT-TPE-01-DE