Last updated on September 2016

Safety Evaluation of Seraph to Reduce Bacteremia in Patients on Hemodialysis


Brief description of study

The purpose of this study is to determine whether the Seraph® Microbind® Affinity Blood Filter is safe in the treatment of dialysis patients with bacteremia from Staphylococcus aureus.

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 including Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) 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® 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, 7 and 14.

Clinical Study Identifier: NCT02914132

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Kathleen A White, B.Sci.

Klinikum Braunschweig
Braunschweig, Germany
  Connect »