Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection.

Completed

Conditions: Sepsis
10027665
10019815

Registration Number: NL-OMON49017

Lead Sponsor: Exthera Medical Europe B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Patients with sepsis and suspected bloodstream infection
2. Be >= 18 years old and <=90 years old
3. Adults receiving antibiotic therapy
4. Increase of at least two points of the Sequential Organ Failure Assessment
(SOFA) score
5. Subjects that presents Procalcitonin (PCT) levels >0,5 ng/mL

Exclusion Criteria

1. Subject is currently participating in another clinical investigation
2. Pregnant or nursing subjects and those who plan pregnancy during the
clinical investigation follow-up period
3. Presence of comorbid conditions, or other medical, social, or psychological
conditions that, in the investigator*s opinion, could limit the subject*s
ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results
4. The first dose of the current antibiotic therapy was > 24 h before screening
5. Have Child-Pugh Class C cirrhosis
6. Have platelet count <30.000/uL
7. Contraindications for heparin sodium for injection
8. Subjects demonstrating any contraindication for this treatment as described
in the IFU

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reduction of pathogens load from the bloodstream during treatment<br /><br>Time frame: [ (4,5 hours ± 30 min) ]</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>All-cause mortality<br /><br>Time frame: [ 90 Days]<br /><br>• Persistence/Recurrence of bacteremia<br /><br>Time frame: [ Day 1, Day 2, Day 7]<br /><br>• Persistence/Recurrence of sepsis<br /><br>Time frame: [ Daily during ICU stay or at least Day 1, Day 2, Day7]<br /><br>Organ dysfunction-free days<br /><br>Time frame: [ Daily during ICU stay or at least Day 1, Day 2, Day 7 ]<br /><br>• Reduction of Intensive Care Unit (ICU) complications<br /><br>Time frame: [ Daily during ICU stay ]<br /><br>• Ventilator-free days (VFDs)<br /><br>Time frame: [ Daily during ICU stay or at least Day 1, Day 2, Day 7 ]<br /><br>• Length of stay (LOS) at ICU and hospital ward<br /><br><br /><br>Safety endpoint<br /><br>N (%) of patients with treatment emergent adverse events</p><br>