Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis (NCT02914132) | Clinical Trial Compass
CompletedNot Applicable
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
Germany15 participantsStarted 2016-02
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.