Clinical trial NCT06382675: Clinical Performance of the New Plasma Filter PX2 in TPE Treatments
Official title: Clinical Performance of the New Plasma Filter PX2 in Combination with the MultiFiltrate and MultiFiltratePRO in TPE Treatments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autoimmune Diseases
Keywords: Therapeutical Plasma Exchange
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: KLIFO GmbH
First posted: 2024-04-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, single arm, multi-centric, open-label
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Analysis of TPE treatments with the Plama Filter PX2
timeFrame: on average 7 weeks depending on on the indication, frequency and number of treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
state: Bavaria
city: Munich
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
state: Bavaria
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
state: Niedersachsen
city: Paderborn
country: Germany
facility: St. Vincenz Kliniken
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Klinikum Aschaffenburg-Alzenau
name: Stefan Büttner, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: