Clinical Performance of the New Plasma Filter PX2 in TPE Treatments

Официальное название

Clinical Performance of the New Plasma Filter PX2 in Combination With the multiFiltrate and multiFiltratePRO in TPE Treatments

Обзор

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.

Вмешательства

• Устройство 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)

Первичные конечные точки

• Analysis of TPE treatments with the Plama Filter PX2 [Срок оценки: on average 7 weeks depending on on the indication, frequency and number of treatments]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 7 центров

• Klinikum Aschaffenburg-Alzenau — Aschaffenburg
• Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum) — Munich
• Städtisches Klinikum Braunschweig — Braunschweig
• St. Vincenz Kliniken — Paderborn
• Charité-Universitätsmedizin Berlin — Berlin
• Universitätsklinikum Ulm — Ulm
• Universitätsklinikum Würzburg — Würzburg

Идентификаторы

NCT: NCT06382675 · TA-PF-01-DE · CIV-23-11-044643

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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