Actively Recruiting
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
Eligibility Criteria
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
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
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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