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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-23-11-044643 | Other Identifier | Unique identification number EUDAMED |
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| Name | Class |
|---|---|
| Alcedis GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Plasma Exchange (TPE) | Other | Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of TPE treatments with the Plama Filter PX2 | 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 | on average 7 weeks depending on on the indication, frequency and number of treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuela Stauss-Grabo, Dr. | Contact | +49 1525 469 1929 | Manuela.Stauss-Grabo1@freseniusmedicalcare.com | |
| Jana Schmitt | Contact | +4961722686305 | jana.schmitt@freseniusmedicalcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Büttner, Dr. med. | Klinikum Aschaffenburg-Alzenau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Aschaffenburg-Alzenau | Recruiting | Aschaffenburg | Bavaria | 63739 | Germany |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
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Interventional, single arm, multi-centric, open-label
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| Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum) | Recruiting | Munich | Bavaria | 81377 | Germany |
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| Städtisches Klinikum Braunschweig | Recruiting | Braunschweig | Lower Saxony | 38126 | Germany |
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| St. Vincenz Kliniken | Recruiting | Paderborn | North Rhine-Westphalia | 33098 | Germany |
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| Charité-Universitätsmedizin Berlin | Recruiting | Berlin | State of Berlin | 13353 | Germany |
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| Universitätsklinikum Ulm | Recruiting | Ulm | 89081 | Germany |
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| Universitätsklinikum Würzburg | Recruiting | Würzburg | 97080 | Germany |
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| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |