Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02914132
Brief 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.
Study:
NCT02914132
Study Brief:
Protocol Section:
NCT02914132