Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
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|ClinicalTrials.gov Identifier: NCT02914132|
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : November 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bacteremia Bacterial Infection||Device: Seraph 100 Filter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing Bacteremia in Patients on Hemodialysis|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||June 7, 2018|
|Actual Study Completion Date :||June 7, 2018|
Seraph 100 Filter
Renal replacement patient with bacteremia.
Device: Seraph 100 Filter
Treatment of renal replacement therapy patients with bacteremia.
Other Name: Seraph 100
- Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. [ Time Frame: 14 days ]Rate of adverse events
- Reduction of bacteria in blood passed through the Seraph 100 filter. [ Time Frame: 4 hours ]Bacteria (CFU/mL or TTP) in blood is measure during the 4 hour treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914132
|Braunschweig, Germany, 38126|
|Hannöver, Germany, 30625|
|Muenster, Germany, 48149|
|Principal Investigator:||Jan T Kielstein, MD,FASN,FERA||Klinikum Braunschweig|