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

2016-09-26 22:23:21 | BioPortfolio

Summary

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.

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bacteremia

Intervention

Seraph Microbind Affinity Blood Filter

Location

Klinikum Braunschweig
Braunschweig
Germany
38126

Status

Recruiting

Source

ExThera Medical Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-26T22:23:21-0400

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