Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

Launched by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Plasma Filter PX2, which is used in a treatment called therapeutic plasma exchange (TPE). TPE is a procedure that helps remove harmful substances from the blood in patients with autoimmune diseases. The trial aims to collect information about how well the PX2 filter works when used with specific blood purification devices called multiFiltrate and multiFiltratePRO. This study does not involve a control group; instead, it reflects routine clinical practice, meaning that the treatments will be decided by the doctors based on their usual care methods.

To participate in this trial, patients must be at least 18 years old and have a need for TPE treatment. They should be able to provide informed consent and have no allergies to the materials used in the PX2 filter. Participants will not have their treatment plan changed because of the study; they will receive the same care as usual. The trial will document up to ten treatments, allowing researchers to gather valuable data on the filter’s performance. Overall, the participation is designed to contribute to understanding the effectiveness of this new technology in helping patients with autoimmune conditions.

Gender

ALL

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