Analysis of therapeutic plasma exchange treatments using multiFiltratePRO
Analysis of TPE Treatments With multiFiltratePRO
This study looks at how well the therapeutic plasma exchange treatment works for patients using the multiFiltratePRO device based on their medical records from the past few years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fresenius Medical Care Deutschland GmbH Industry-sponsored |
| Locations | 3 sites (Aschaffenburg, Bavaria and 2 other locations) |
| Trial ID | NCT06272084 on ClinicalTrials.gov |
What this trial studies
This study analyzes the performance of the therapeutic plasma exchange (TPE) mode of the multiFiltratePRO device, which is used for extracorporeal blood purification. It is a retrospective, open, non-comparative, multi-centric post-market clinical follow-up study that collects treatment data from medical records of patients treated with TPE between January 2019 and October 2023. The aim is to reflect daily clinical practice and contribute empirical evidence regarding the effectiveness of the TPE mode. The study does not involve any control treatments and focuses solely on the documented outcomes of the TPE treatments.
Who should consider this trial
Good fit: Ideal candidates include patients weighing at least 40 kg who have an indication for TPE treatment according to ASFA guidelines and have been treated with TPE between January 2019 and October 2023.
Not a fit: Patients currently participating in an interventional clinical study or those who have previously been documented in this study may not receive any benefit.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of TPE treatments for patients with autoimmune diseases.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating therapeutic plasma exchange, but this specific analysis is focused on a particular device and its performance.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aschaffenburg, Bavaria and 2 other locations
- Klinikum Aschaffenburg-Alzenau — Aschaffenburg, Bavaria, Germany (Recruiting)
- Universitätsklinikum Würzburg — Würzburg, Bavaria, Germany (Recruiting)
- Charité-Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Stefan Büttner, Dr. med. — Klinikum Aschaffenburg-Alzenau
- Study coordinator: Manuela Stauss-Grabo, Dr.
- Email: Manuela.Stauss-Grabo1@freseniusmedicalcare.com
- Phone: +4915254601929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.