NCT06272084

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 22, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

February 5, 2024

Last Update Submit

August 27, 2025

Conditions

Keywords

Therapeutical Plasma ExchangeASFA Guideline

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 1 year

Study Arms (1)

TPE Treatments

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

Device: Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO

Interventions

Retrospective Data Analysis of TPE treatments with multiFiltratePRO

TPE Treatments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Bavaria, 63739, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Charité-Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Stefan Büttner, Dr. med.

    Klinikum Aschaffenburg-Alzenau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 22, 2024

Study Start

May 22, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations