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Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis

Primary Purpose

Bacteremia, Bacterial Infection

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Seraph 100 Filter

About this trial

This is an interventional treatment trial for Bacteremia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Require renal replacement therapy.
Be ≥ 18 years old and ≤ 90 years old
Positive blood culture and one of the following:
1. Clinical evidence of a catheter exit site to tunnel infection as evidenced by redness, tenderness or purulence.
2. Bacteremia is proven with two separate blood cultures from independent vein punctures.
3. A blood culture with Staphylococcus aureus where the time to positivity is within 14 hours.
4. 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:
1. Have heparin sensitivity
2. Severe thrombocytopenia.
3. With an uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation
4. 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)

Sites / Locations

Klinikum Braunschweig
Universitaetsklinikum-Frankfurt
Medizinische Hochschule-Hannover
Universitatsklinikum Muenster

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Seraph 100 Filter

Arm Description

Renal replacement patient with bacteremia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02914132

First Posted

September 22, 2016

Last Updated

June 27, 2019

Sponsor

ExThera Medical Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02914132

Brief Title

Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis

Official Title

Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing Bacteremia in Patients on Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

June 7, 2018 (Actual)

Study Completion Date

June 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ExThera Medical Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacteremia, Bacterial Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Seraph 100 Filter

Arm Type

Other

Arm Description

Renal replacement patient with bacteremia.

Intervention Type

Device

Intervention Name(s)

Seraph 100 Filter

Other Intervention Name(s)

Seraph 100

Intervention Description

Treatment of renal replacement therapy patients with bacteremia.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

14 days

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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 <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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan T Kielstein, MD,FASN,FERA

Organizational Affiliation

Klinikum Braunschweig

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum Braunschweig

City

Braunschweig

ZIP/Postal Code

38126

Country

Germany

Facility Name

Universitaetsklinikum-Frankfurt

City

Frankfurt

Country

Germany

Facility Name

Medizinische Hochschule-Hannover

City

Hannöver

ZIP/Postal Code

30625

Country

Germany

Facility Name

Universitatsklinikum Muenster

City

Muenster

ZIP/Postal Code

48149

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35715801

Citation

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.

Results Reference

derived

Learn more about this trial

Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis

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