Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06382675

Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

Led by Fresenius Medical Care Deutschland GmbH · Updated on 2025-03-17

46

Participants Needed

5

Research Sites

84 weeks

Total Duration

On this page

Sponsors

F

Fresenius Medical Care Deutschland GmbH

Lead Sponsor

K

KLIFO GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by the patient and authorized physician
  • Minimum age of 18 years
  • Patients with an indication for therapeutic 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
Not Eligible

You will not qualify if you...

  • Known or suspected hypersensitivity to any materials of the PX2 plasma filter or related products (Polysulfone, Polyvinylpyrrolidone, Polypropylene, Polyurethane, Silicone)
  • Heparin allergy
  • Prescription for TPE treatment with plasma volume exchange completion less than 0.8 PV or greater than 2.0 PV
  • Any condition interfering with the patient's ability to comply with the study
  • Women under 55 years of childbearing age without effective contraception, pregnant women, or those in lactation
  • Participation in another interventional clinical study within the past 30 days
  • Previous participation in this investigation

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Bavaria, Germany, 63739

Actively Recruiting

2

Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)

Munich, Bavaria, Germany, 81377

Actively Recruiting

3

Städtisches Klinikum Braunschweig

Braunschweig, Lower Saxony, Germany, 38126

Actively Recruiting

4

St. Vincenz Kliniken

Paderborn, North Rhine-Westphalia, Germany, 33098

Actively Recruiting

5

Charité-Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 13353

Actively Recruiting

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Research Team

M

Manuela Stauss-Grabo, Dr.

CONTACT

J

Jana Schmitt

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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