Clinical Performance of the New Plasma Filter PX2 in TPE Treatments (plasmaFlux)

Fresenius Medical Care (FMC)

Status

Enrolling

Conditions

Autoimmune Diseases

Treatments

Device: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06382675

TA-PF-01-DE

CIV-23-11-044643 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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