NCT02914132

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

Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing Bacteremia in Patients on Hemodialysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: ExThera Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Bacteremia
• Bacterial Infection

Interventions

Type	Name	Description
DEVICE	Seraph 100 Filter	Treatment of renal replacement therapy patients with bacteremia.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2016-09-26
• Last updated: 2019-08-12
• Results posted: 2019-08-12

Locations

4 sites across 1 country: Germany