Last updated on February 2018

Safety Evaluation of Seraph 100 to Reduce Bacteremia in Patients on Hemodialysis

Brief description of study

The purpose of this study is to determine whether the Seraph 100 Microbind Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.

Detailed Study Description

This trial is a prospective, non-randomized study in patients as an adjunctive treatment for blood stream infection (BSI) in patients on renal replacement therapy. The heparin surface being studied is currently marketed on extracorporeal circuits. It has been shown to absorb various types of Gram positive and Gram negative bacteria and to reduce toxins and cytokines in in vitro studies using whole blood. For this study, patients on renal replacement therapy who develop bacteremia will have the Seraph 100 Microbind Affinity Blood Filter included in the dialysis circuit for up to 4 hours, on one day, with hourly monitoring. Patients will be followed for 14 days post treatment. Patients will be monitored by vital signs and laboratory indices on the day of treatment and on post procedure day 1, 2, 3, 4, 5, 6, 7 and 14.

Clinical Study Identifier: NCT02914132

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Kathleen A White, B.Sci.

Klinikum Braunschweig
Braunschweig, Germany
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Jan Menne, Prof.

Medizinische Hochschule-Hannover
Hannöver, Germany
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Philipp Kuempers, Prof.

Universitatsklinikum Muenster
Muenster, Germany
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