Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

NCT06382675 — Not applicable, Recruiting, 46 participants, Fresenius Medical Care Deutschland GmbH

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Clinical Performance of the New Plasma Filter PX2 in Combination With the multiFiltrate and multiFiltratePRO in TPE Treatments

Registry	NCT06382675, acronym plasmaFlux
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	46 (Estimated)
Sponsor	Fresenius Medical Care Deutschland GmbH (Industry); collaborators: Alcedis GmbH
Conditions	Autoimmune Diseases
Interventions	Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 (Device)
Dates	start 2024-07-18, primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2024-04-24, last updated 2026-06-24
Locations	7 sites in Germany

-Summary

The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.

The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. 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 new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment.

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+Arms and interventions

Arm	Type	Interventions	Description
Therapeutic Plasma Exchange (TPE)	Other	Device: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2	Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline

Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 (Device): 230 evaluable TPE treatments will be documented in the study (with an average of 5-7 TPE treatments per patient this corresponds to approximately 46 patients)

+Outcome measures

Primary outcomes

Analysis of TPE treatments with the Plama Filter PX2 [on average 7 weeks depending on on the indication, frequency and number of treatments]: Investigation of clinical performance of the new plasma filter PX2 by assessing the completion of the prescribed plasma volume (PV) in ≥ 75% of all TPE procedures

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (7)

Facility	City	Country	Status
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
Universitätsklinikum Würzburg	Würzburg	Germany	Recruiting

+Investigators

Stefan Büttner, Dr. med., Principal investigator, Klinikum Aschaffenburg-Alzenau