Analysis of TPE Treatments With multiFiltratePRO
ConditionAutoimmune Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFresenius Medical Care Deutschland GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body weight ≥40kg irrespective of the age
Patients with indication for TPE treatment according to ASFA guideline
Patients have been treated with TPE between January 2019 and October 2023
Availability of at least 50% of the parameters to be documented for the patient
Disqualifiers
Participation in an interventional clinical study during the retrospectively collected TPE treatment data
Previous documentation within this study
Simultaneous use of another filter for additional therapy form
Trial population
Patients with indication for TPE treatment according to ASFA (American Society for Apheresis) guideline treated with TPE between January 2019 and October 2023.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Therapeutic Plasma Exchange (TPE) option of multiFiltratePRO
DeviceRetrospective Data Analysis of TPE treatments with multiFiltratePRO
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: TPE Treatments1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fresenius Medical Care Deutschland GmbH
Lead sponsor
X-act Cologne Clinical Research GmbH
Collaborator
Source ClinicalTrials.gov