N/A
N=15
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
Bacteremia · Bacterial Infection
Bottom Line
View on ClinicalTrials.gov: NCT02914132 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events. — 0 Percent participants w adverse event
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Seraph 100 Filter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ExThera Medical Corporation
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events. |
— | — |
| SECONDARY Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter. |
4 | — |
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.
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT02914132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.