Analysis of TPE Treatments With multiFiltratePRO

NCT ID: NCT06272084

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-22

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Autoimmune Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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TPE Treatments

Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline

Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO

Intervention Type DEVICE

Retrospective Data Analysis of TPE treatments with multiFiltratePRO

Interventions

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Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO

Retrospective Data Analysis of TPE treatments with multiFiltratePRO

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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X-act Cologne Clinical Research GmbH

INDUSTRY

Sponsor Role collaborator

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Büttner, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Aschaffenburg-Alzenau

Locations

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Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Bavaria, Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Site Status RECRUITING

Charité-Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Manuela Stauss-Grabo, Dr.

Role: CONTACT

+4915254601929

Anna Wammi

Role: CONTACT

+49 6172 2686700

Facility Contacts

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Stefan Büttner, Dr. med.

Role: primary

Anna Herzog, Dr. med.

Role: primary

Eva-Vanessa Schrezenmeier, Dr. med.

Role: primary

Other Identifiers

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CRRT-TPE-01-DE

Identifier Type: -

Identifier Source: org_study_id

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