NCT02914132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 12, 2019

Completed
Last Updated

August 12, 2019

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

September 22, 2016

Results QC Date

June 27, 2019

Last Update Submit

June 27, 2019

Conditions

BacteremiaBacterial Infection

Outcome Measures

Primary Outcomes (1)

  • Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.

    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 Outcomes (1)

  • Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter.

    4 hours

Study Arms (1)

Seraph 100 Filter

OTHER

Renal replacement patient with bacteremia.

Device: Seraph 100 Filter

Interventions

Seraph 100 FilterDEVICE

Treatment of renal replacement therapy patients with bacteremia.

Also known as: Seraph 100
Seraph 100 Filter

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Universitaetsklinikum-Frankfurt

Frankfurt, Germany

Location

Medizinische Hochschule-Hannover

Hannover, 30625, Germany

Location

Universitatsklinikum Muenster

Münster, 48149, Germany

Location

Related Publications (1)

  • Eden G, Schmidt JJ, Buttner S, Kumpers P, Hafer C, Rovas A, Koch BF, Schmidt BMW, Kielstein JT. Safety and efficacy of the Seraph(R) 100 Microbind(R) Affinity Blood Filter to remove bacteria from the blood stream: results of the first in human study. Crit Care. 2022 Jun 17;26(1):181. doi: 10.1186/s13054-022-04044-7.

    PMID: 35715801DERIVED

MeSH Terms

Conditions

BacteremiaBacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sr. Director of Regulatory and Clinical Affairs
Organization
ExThera Medical Corporation
erdie@extheramedical.com
9258392079

Study Officials

  • Jan T Kielstein, MD,FASN,FERA

    Academic Teaching Hospital Braunschweig

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2016

First Posted

September 26, 2016

Study Start

February 1, 2016

Primary Completion

June 7, 2018

Study Completion

June 7, 2018

Last Updated

August 12, 2019

Results First Posted

August 12, 2019

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)