Clinical Performance of the New Plasma Filter PX2 in TPE Treatments
NCT ID: NCT06382675
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2024-07-18
2026-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapeutic Plasma Exchange (TPE)
Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline
Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
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)
Interventions
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Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2
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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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KLIFO GmbH
UNKNOWN
Fresenius Medical Care Deutschland GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Stefan Büttner, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Klinikum Aschaffenburg-Alzenau
Locations
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Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Bavaria, Germany
Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
Munich, Bavaria, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, Germany
St. Vincenz Kliniken
Paderborn, North Rhine-Westphalia, Germany
Charité-Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIV-23-11-044643
Identifier Type: OTHER
Identifier Source: secondary_id
TA-PF-01-DE
Identifier Type: -
Identifier Source: org_study_id
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