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| Name | Class |
|---|---|
| X-act Cologne Clinical Research GmbH | INDUSTRY |
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Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.
The study is a retrospective, open, non-comparative, multi-centric PMCF study. The investigational device has CE approval. The investigation involves the retrospective collection of treatment data for the TPE treatment mode from the medical records. 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 TPE mode of the multiFiltratePRO system.
The site will document the treatment data of patients with an indication for the TPE treatment who had been treated with the investigational devices under the TPE treatment mode between 2019 and October 2023 in chronological order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPE Treatments | Patients with indication for TPE treatment according to American Society for Apheresis (ASFA) guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO | Device | Retrospective Data Analysis of TPE treatments with multiFiltratePRO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of exchange plasma (prescribed vs achieved exchange volume) | Statistical analysis is performed on retrospective data (Treatments between 2019 and October 2023). Primary goal of the study is to prove that the prescribed therapeutic plasma exchange rate during treatment was achieved in > 70% of treatments and therefore was in alignment with current guidelines. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuela Stauss-Grabo, Dr. | Contact | +4915254601929 | Manuela.Stauss-Grabo1@freseniusmedicalcare.com | |
| Anna Wammi | Contact | +49 6172 2686700 | anna.wammi@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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| Universitätsklinikum Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
|
| Charité-Universitätsmedizin Berlin | Recruiting | Berlin | State of Berlin | 13353 | Germany |
|
| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |