Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

Study summary

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.

Eligibility

Primary outcome measure(s)

• Analysis of TPE treatments with the Plama Filter PX2 — on average 7 weeks depending on on the indication, frequency and number of treatments
  Investigation of clinical performance of the new plasma filter PX2 by assessing the completion of the prescribed plasma volume (PV) in ≥ 75% of all TPE procedures

Trial sites (7)

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