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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02914132
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Information provided by (Responsible Party):
ExThera Medical Corporation

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 Phase
Bacteremia Bacterial Infection Device: Seraph 100 Filter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
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
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Safety

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

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 ]
    Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. No adverse events occured

Secondary Outcome Measures :
  1. Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter. [ Time Frame: 4 hours ]
    Pathogen reduction of > 40 % as CFU/mL or an increase in time to positivity (TTP) of > 22 minutes in blood passed through the Seraph 100 Filter

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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)

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 identifier (NCT number): NCT02914132

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Klinikum Braunschweig
Braunschweig, Germany, 38126
Frankfurt, Germany
Medizinische Hochschule-Hannover
Hannöver, Germany, 30625
Universitatsklinikum Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
ExThera Medical Corporation
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Principal Investigator: Jan T Kielstein, MD,FASN,FERA Klinikum Braunschweig
  Study Documents (Full-Text)

Documents provided by ExThera Medical Corporation:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ExThera Medical Corporation Identifier: NCT02914132    
Other Study ID Numbers: CP001
First Posted: September 26, 2016    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bacterial Infections
Bacterial Infections and Mycoses
Systemic Inflammatory Response Syndrome
Pathologic Processes