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

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ClinicalTrials.gov Identifier: NCT02914132
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Bacteremia Bacterial Infection Device: Seraph 100 Filter

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing Bacteremia in Patients on Hemodialysis
Study Start Date : February 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Seraph 100 Filter
Renal replacement patient with bacteremia.
Device: Seraph 100 Filter
Treatment of renal replacement therapy patients with bacteremia.
Other Name: Seraph 100


Outcome Measures

Primary Outcome Measures :
  1. Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. [ Time Frame: 14 days ]
    Rate of adverse events


Secondary Outcome Measures :
  1. Reduction of bacteria in blood passed through the Seraph 100 filter. [ Time Frame: 4 hours ]
    Bacteria (CFU/mL or TTP) in blood is measure during the 4 hour treatment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914132


Contacts
Contact: Kathleen A White, B.Sci. 510-809-2515 kathleen.white@extheramedical.com

Locations
Germany
Klinikum Braunschweig Recruiting
Braunschweig, Germany, 38126
Medizinische Hochschule-Hannover Recruiting
Hannöver, Germany, 30625
Contact: Jan Menne, Prof.    05115323000    menne.jan@mh-hannover.de   
Universitatsklinikum Muenster Recruiting
Muenster, Germany, 48149
Contact: Philipp Kuempers, Prof.    0251830    philipp.Kuempers@ukmuenster.de   
Sponsors and Collaborators
ExThera Medical Corporation
Investigators
Principal Investigator: Jan T Kielstein, MD,FASN,FERA Klinikum Braunschweig
More Information

Responsible Party: ExThera Medical Corporation
ClinicalTrials.gov Identifier: NCT02914132     History of Changes
Other Study ID Numbers: CP001
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Bacterial Infections
Bacteremia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes