Analysis of TPE Treatments With multiFiltratePRO (TPEopt)

Fresenius Medical Care (FMC)

Status

Enrolling

Conditions

Autoimmune Diseases

Treatments

Device: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO

Study type

Observational

Funder types

Industry

Identifiers

NCT06272084

CRRT-TPE-01-DE

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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