Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
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.
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.
Inclusion Criteria:

 1. Require renal replacement therapy.

 2. Be ≥ 18 years old and ≤ 90 years old

 3. Positive blood culture and one of the following:

 1. Clinical evidence of a catheter exit site to tunnel infection as evidenced by
 redness, tenderness or purulence.

 2. Bacteremia is proven with two separate blood cultures from independent vein
 punctures.

 3. A blood culture with Staphylococcus aureus where the time to positivity is within
 14 hours.

 4. Growth from a blood culture taken from the hemodialysis catheter 2 or more hours
 before the growth of a blood culture drawn peripherally at the same time.

 Exclusion Criteria:

 1. Have an arteriovenous polytetrafluoroethylene (PTFE) graft.

 2. Lack of a commitment to full aggressive support.

 3. Have inability to maintain a minimum mean arterial pressure of ≥ 65 mm Hg despite
 vasopressor therapy and fluid resuscitation.

 4. Have had chest compressions as part of cardiopulmonary resuscitation (CPR)

 5. Have had an acute myocardial infarction (MI) within the past 3 months.

 6. Have had serious injury within 36 hours of screening.

 7. Have uncontrolled hemorrhage.

 8. Are not expected to live > 14 days.

 9. Have malignancy and are not expected to live 42 days.

 10. Have neutropenia (absolute neutrophil count <500 cells/µL).

 11. Have Child-Pugh Class C cirrhosis.

 12. Have New York Heart Association Class IV Heart Failure or an ejection fraction <30%.

 13. Have known Antithrombin III deficiency.

 14. Have platelet count <30,000/µL.

 15. Cannot have intravenous (IV) supplemental iron halted during trial period.

 16. Are currently involved in an investigational drug or device trial.

 17. Have been previously enrolled in this clinical trial.

 18. Next hemodialysis treatment will not take place for at least 24 hours after
 enrollment.

 19. Serious bleedings and clotting disorders, determined by blood transfusion of > 2 units
 of packed red blood cells, or, An acute (48 h) hemoglobin decline of at least 2 g/dL,
 transfusion requirement of >4 units over 48h, objective evidence of bleed, documented
 by physician.

 20. Breast feeding and pregnant women

 21. Contraindications for heparin sodium for injection are:

 1. Have heparin sensitivity

 2. Severe thrombocytopenia.

 3. With an uncontrolled active bleeding state, except when this is due to
 disseminated intravascular coagulation

 4. In whom suitable blood coagulation tests, e.g. whole blood clotting time, partial
 thromboplastin time, etc cannot be performed at appropriate intervals (this
 contraindication refers to full-dose heparin; there is usually no need to monitor
 coagulation parameters in patients receiving low-dose heparin)