- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02914132
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
June 27, 2019 updated by: ExThera Medical Corporation
Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Braunschweig, Germany, 38126
- Klinikum Braunschweig
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Frankfurt, Germany
- Universitaetsklinikum-Frankfurt
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Hannöver, Germany, 30625
- Medizinische Hochschule-Hannover
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Muenster, Germany, 48149
- Universitätsklinikum Muenster
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Require renal replacement therapy.
- Be ≥ 18 years old and ≤ 90 years old
Positive blood culture and one of the following:
- Clinical evidence of a catheter exit site to tunnel infection as evidenced by redness, tenderness or purulence.
- Bacteremia is proven with two separate blood cultures from independent vein punctures.
- A blood culture with Staphylococcus aureus where the time to positivity is within 14 hours.
- 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:
- Have an arteriovenous polytetrafluoroethylene (PTFE) graft.
- Lack of a commitment to full aggressive support.
- Have inability to maintain a minimum mean arterial pressure of ≥ 65 mm Hg despite vasopressor therapy and fluid resuscitation.
- Have had chest compressions as part of cardiopulmonary resuscitation (CPR)
- Have had an acute myocardial infarction (MI) within the past 3 months.
- Have had serious injury within 36 hours of screening.
- Have uncontrolled hemorrhage.
- Are not expected to live > 14 days.
- Have malignancy and are not expected to live 42 days.
- Have neutropenia (absolute neutrophil count <500 cells/µL).
- Have Child-Pugh Class C cirrhosis.
- Have New York Heart Association Class IV Heart Failure or an ejection fraction <30%.
- Have known Antithrombin III deficiency.
- Have platelet count <30,000/µL.
- Cannot have intravenous (IV) supplemental iron halted during trial period.
- Are currently involved in an investigational drug or device trial.
- Have been previously enrolled in this clinical trial.
- Next hemodialysis treatment will not take place for at least 24 hours after enrollment.
- 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.
- Breast feeding and pregnant women
Contraindications for heparin sodium for injection are:
- Have heparin sensitivity
- Severe thrombocytopenia.
- With an uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Seraph 100 Filter
Renal replacement patient with bacteremia.
|
Treatment of renal replacement therapy patients with bacteremia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan T Kielstein, MD,FASN,FERA, Klinikum Braunschweig
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
June 7, 2018
Study Completion (Actual)
June 7, 2018
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 22, 2016
First Posted (Estimate)
September 26, 2016
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
June 27, 2019
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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