Analysis of TPE Treatments With multiFiltratePRO

Autoimmune Diseases Clinical Trial

— TPEopt  

Official title:

Analysis of TPE Treatments With multiFiltratePRO

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272084
• Other study ID #: CRRT-TPE-01-DE
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Manuela Stauss-Grabo, Dr.
• Phone: +4915254601929
• Email: Manuela.Stauss-Grabo1[@]freseniusmedicalcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Device:
• Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO
Retrospective Data Analysis of TPE treatments with multiFiltratePRO

Locations

Country	Name	City	State
Germany	Klinikum Aschaffenburg-Alzenau	Aschaffenburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	X-act Cologne Clinical Research GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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