Using a new plasma filter for blood purification in autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the performance of the new Plasma Filter PX2 during therapeutic plasma exchange (TPE) treatments for patients with autoimmune diseases. The study collects treatment data using the PX2 filter in conjunction with the multiFiltrate and multiFiltratePRO devices, focusing on its effectiveness in separating plasma from blood. It is designed as a one-arm study to reflect real-world clinical practice without control treatments, allowing for empirical evidence to be gathered on the filter's performance. There is no specific treatment schedule defined, providing flexibility in the application of TPE.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorized physician
* Minimum age of 18 years
* Patients with an indication for a therapeutical plasma exchange
* Patients to be treated with the plasma filter PX2 in combination with the multiFiltrate or multiFiltratePRO
* No contraindication against systemic anticoagulation
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Patients with known or suspected hypersensitivity to any of the materials of the PX2 plasma filter (Polysulfone, Polyvinylpyrrolidone, Polypropylene, Polyurethane, Silicone) and trial related products
* Patients suffering from a heparin allergy
* Patients with a prescription for TPE treatment with the completion of \< 0.8 PV and \> 2.0 PV
* Any conditions which could interfere with the patient's ability to comply with the study
* Women of childbearing age (\< 55 years) without effective means of contraception, pregnancy (pregnancy test will be conducted at start) or lactation period
* Participation in a different interventional clinical study during the preceding 30 days
* Previous participation in this investigation

Where it's running

• Klinikum Aschaffenburg-Alzenau
  Aschaffenburg, Bavaria, Germany Recruiting
• Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
  Munich, Bavaria, Germany Recruiting
• Städtisches Klinikum Braunschweig
  Braunschweig, Lower Saxony, Germany Recruiting
• St. Vincenz Kliniken
  Paderborn, North Rhine-Westphalia, Germany Recruiting
• Charité-Universitätsmedizin Berlin
  Berlin, State of Berlin, Germany Recruiting
• Universitätsklinikum Ulm
  Ulm, 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: +49 1525 469 1929

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.