Autoimmune Diseases
Conditions
Keywords
Therapeutical Plasma Exchange
Brief 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.
Interventions
DEVICETherapeutic 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)
Sponsors
Fresenius Medical Care Deutschland GmbH
Alcedis GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Interventional, single arm, multi-centric, open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
CONTACTManuela Stauss-Grabo, Dr.
CONTACTJana Schmitt
PRINCIPAL_INVESTIGATORStefan Büttner, Dr. med.
Klinikum Aschaffenburg-Alzenau
Outcome results
None listed