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Article ; Online: Using the Seraph® 100 Microbind® Affinity blood filter under slow flow conditions through 18 G and 16 G central lines.

Seffer, Malin-Theres / Meyer, Torsten M / Borchina, Dan-Nicolae / Kielstein, Jan T / Schmidt, Julius J

2024 , Page(s) 11297298241234073

Abstract: Introduction: The Seraph® 100 Microbind® Affinity blood filter (Seraph® 100) has been in use since 2019 for the treatment of fulminant or difficult to treat blood stream infections as an adjunct to pharmacotherapy. In 2020 the device received emergency ... ...

Abstract	Introduction: The Seraph® 100 Microbind® Affinity blood filter (Seraph® 100) has been in use since 2019 for the treatment of fulminant or difficult to treat blood stream infections as an adjunct to pharmacotherapy. In 2020 the device received emergency use authorization by the US Food and Drug Administration for the treatment of critically ill COVID-19 patients with confirmed or imminent respiratory failure. Results of an international registry showed that the Seraph® 100 was operated under blood flow rates of 100-350 mL/min. As those conditions require a large bore central line, a dialysis catheter is currently considered indispensable to operate the Seraph® 100. The use of smaller catheter lumina has neither been evaluated in vitro nor in vivo. Methods: In vitro pressure data before and after the Seraph® 100 at various blood pump rates (prepump line 16 G, postpump line 18 G) with saline and human plasma were obtained. Further, anecdotal flow and pressure data of two patients treated with the Seraph® 100 for a COVID-19 infection are reported. Results: At a pump speed of 50 mL/min pre-Seraph® pressure using saline was -70 [-70 to -60] mm Hg. In comparison, using plasma pre-Seraph® pressure was lower at -120 [-120 to -105] mm Hg; Conclusion: Seraph® 100 blood flow rate of 50 mL/min may be achieved using low flow vascular access, allowing to treat a blood volume 72 L in 24 h.
Language	English
Publishing date	2024-02-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	2252820-9
ISSN	1724-6032 ; 1129-7298
ISSN (online)	1724-6032
ISSN	1129-7298
DOI	10.1177/11297298241234073
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Article ; Online: Staphylococcus aureus binding to Seraph® 100 Microbind® Affinity Filter

Malin-Theres Seffer / Martin Weinert / Gabriella Molinari / Manfred Rohde / Lothar Gröbe / Jan T Kielstein / Susanne Engelmann

PLoS ONE, Vol 18, Iss 3, p e

Effects of surface protein expression and treatment duration.

2023 Volume 0283304

Abstract: Introduction Extracorporeal blood purification systems represent a promising alternative for treatment of blood stream infections with multiresistant bacteria. Objectives The aim of this study was to analyse the binding activity of S. aureus to Seraph ... ...

Abstract	Introduction Extracorporeal blood purification systems represent a promising alternative for treatment of blood stream infections with multiresistant bacteria. Objectives The aim of this study was to analyse the binding activity of S. aureus to Seraph affinity filters based on heparin coated beads and to identify effectors influencing this binding activity. Results To test the binding activity, we used gfp-expressing S. aureus Newman strains inoculated either in 0.9% NaCl or in blood plasma and determined the number of unbound bacteria by FACS analyses after passing through Seraph affinity filters. The binding activity of S. aureus was clearly impaired in human plasma: while a percent removal of 42% was observed in 0.9% NaCl (p-value 0.0472) using Seraph mini columns, a percent removal of only 10% was achieved in human plasma (p-value 0.0934). The different composition of surface proteins in S. aureus caused by the loss of SarA, SigB, Lgt, and SaeS had no significant influence on its binding activity. In a clinically relevant approach using the Seraph® 100 Microbind® Affinity Filter and 1000 ml of human blood plasma from four different donors, the duration of treatment was shown to have a critical effect on the rate of bacterial reduction. Within the first four hours, the number of bacteria decreased continuously and the reduction in bacteria reached statistical significance after two hours of treatment (percentage reduction 64%, p-value 0.01165). The final reduction after four hours of treatment was close to 90% and is dependent on donor. The capacity of Seraph® 100 for S. aureus in human plasma was approximately 5 x 108 cells. Conclusions The Seraph affinity filter, based on heparin-coated beads, is a highly efficient method for reducing S. aureus in human blood plasma, with efficiency dependent on blood plasma composition and treatment duration.
Keywords	Medicine ; R ; Science ; Q
Subject code	630
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Staphylococcus aureus binding to Seraph® 100 Microbind® Affinity Filter: Effects of surface protein expression and treatment duration.

Seffer, Malin-Theres / Weinert, Martin / Molinari, Gabriella / Rohde, Manfred / Gröbe, Lothar / Kielstein, Jan T / Engelmann, Susanne

PloS one

2023 Volume 18, Issue 3, Page(s) e0283304

Abstract: Introduction: Extracorporeal blood purification systems represent a promising alternative for treatment of blood stream infections with multiresistant bacteria.: Objectives: The aim of this study was to analyse the binding activity of S. aureus to ... ...

Abstract	Introduction: Extracorporeal blood purification systems represent a promising alternative for treatment of blood stream infections with multiresistant bacteria. Objectives: The aim of this study was to analyse the binding activity of S. aureus to Seraph affinity filters based on heparin coated beads and to identify effectors influencing this binding activity. Results: To test the binding activity, we used gfp-expressing S. aureus Newman strains inoculated either in 0.9% NaCl or in blood plasma and determined the number of unbound bacteria by FACS analyses after passing through Seraph affinity filters. The binding activity of S. aureus was clearly impaired in human plasma: while a percent removal of 42% was observed in 0.9% NaCl (p-value 0.0472) using Seraph mini columns, a percent removal of only 10% was achieved in human plasma (p-value 0.0934). The different composition of surface proteins in S. aureus caused by the loss of SarA, SigB, Lgt, and SaeS had no significant influence on its binding activity. In a clinically relevant approach using the Seraph® 100 Microbind® Affinity Filter and 1000 ml of human blood plasma from four different donors, the duration of treatment was shown to have a critical effect on the rate of bacterial reduction. Within the first four hours, the number of bacteria decreased continuously and the reduction in bacteria reached statistical significance after two hours of treatment (percentage reduction 64%, p-value 0.01165). The final reduction after four hours of treatment was close to 90% and is dependent on donor. The capacity of Seraph® 100 for S. aureus in human plasma was approximately 5 x 108 cells. Conclusions: The Seraph affinity filter, based on heparin-coated beads, is a highly efficient method for reducing S. aureus in human blood plasma, with efficiency dependent on blood plasma composition and treatment duration.
MeSH term(s)	Humans ; Staphylococcus aureus ; Duration of Therapy ; Membrane Proteins/metabolism ; Saline Solution/pharmacology ; Staphylococcal Infections ; Bacteria ; Heparin/pharmacology
Chemical Substances	Membrane Proteins ; Saline Solution ; Heparin (9005-49-6)
Language	English
Publishing date	2023-03-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0283304
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Elimination of

Seffer, Malin-Theres / Eden, Gabriele / Engelmann, Susanne / Kielstein, Jan T

BMJ case reports

2020 Volume 13, Issue 8

Abstract: Removal of bacteria from the blood by means of extracorporeal techniques has been attempted for decades. In late 2019, the European Union licensed the first ever haemoperfusion device for removal of bacteria from the blood. The active ingredient of ... ...

Abstract	Removal of bacteria from the blood by means of extracorporeal techniques has been attempted for decades. In late 2019, the European Union licensed the first ever haemoperfusion device for removal of bacteria from the blood. The active ingredient of Seraph 100 Microbind Affinity Blood Filter is ultrahigh molecular weight polyethylene beads with endpoint-attached heparin. Bacteria have been shown to bind to heparin as they would usually do to the heparan sulfate on the cell surface, thereby being removed from the blood stream. We describe the first case of a female chronic haemodialysis patient in which this device was clinically used for a
MeSH term(s)	Aged ; Bacteremia/prevention & control ; Bacteremia/therapy ; Biomimetics ; Equipment Design ; Female ; Hemoperfusion/instrumentation ; Humans ; Renal Dialysis ; Staphylococcal Infections/prevention & control ; Staphylococcal Infections/therapy ; Staphylococcus aureus/isolation & purification
Language	English
Publishing date	2020-08-24
Publishing country	England
Document type	Case Reports ; Journal Article
ISSN	1757-790X
ISSN (online)	1757-790X
DOI	10.1136/bcr-2020-235262
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Article ; Online: Elimination of Staphylococcus aureus from the bloodstream using a novel biomimetic sorbent haemoperfusion device.

Seffer, Malin-Theres / Eden, Gabriele / Engelmann, Susanne / Kielstein, Jan T

13 ; 8 ; BMJ case reports ; England

2022

Abstract	Removal of bacteria from the blood by means of extracorporeal techniques has been attempted for decades. In late 2019, the European Union licensed the first ever haemoperfusion device for removal of bacteria from the blood. The active ingredient of Seraph 100 Microbind Affinity Blood Filter is ultrahigh molecular weight polyethylene beads with endpoint-attached heparin. Bacteria have been shown to bind to heparin as they would usually do to the heparan sulfate on the cell surface, thereby being removed from the blood stream. We describe the first case of a female chronic haemodialysis patient in which this device was clinically used for a Staphylococcus aureus infection that persisted for 4 days despite antibiotic therapy. After a single treatment, the bacterial load decreased and the blood cultures at the end of a 4 hour haemoperfusion exhibited no bacterial growth.
Keywords	dialysis ; drugs: infectious diseases ; infections ; therapeutic indications
Language	English
Publishing date	2022-05-06
Publishing country	de
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Heparin 2.0: A New Approach to the Infection Crisis.

Seffer, Malin-Theres / Cottam, Daniel / Forni, Lui G / Kielstein, Jan T

Blood purification

2020 Volume 50, Issue 1, Page(s) 28–34

Abstract: In April 2020, the US Food and Drug Administration granted emergency use authorization for certain medical devices to be used in patients with coronavirus disease 2019 (CO-VID-19). This included extracorporeal blood purification devices. This narrative ... ...

Abstract	In April 2020, the US Food and Drug Administration granted emergency use authorization for certain medical devices to be used in patients with coronavirus disease 2019 (CO-VID-19). This included extracorporeal blood purification devices. This narrative review will give a brief overview regarding some of the extracorporeal devices that could be used to treat COVID-19 patients, including the Seraph® 100 Microbind® Affinity Blood Filter, produced by ExThera Medical (Martinez, CA, USA), first licensed in the European Economic Area in 2019. The Seraph® 100 contains ultrahigh molecular weight polyethylene beads with end point-attached heparin and is approved for the reduction of pathogens from the bloodstream either as a single agent or as an adjunct to conventional anti-infective agents. Bacteria, viruses, fungi, and toxins have been shown to bind to the immobilized heparin in a similar way to the interaction with heparan sulfate on the cell surface. This binding is nonreversible and as such, the pathogens are removed from the bloodstream. In this review, we describe the pathophysiological basis and rationale for using heparin for pathogen removal from the blood as well as exploring the technology behind the adaptation of heparin to deprive it of its systemic anticoagulant activity. In addition, we summarize the in vitro data as well as the available preclinical testing and published clinical reports. Finally, we discuss the enormous potential of this technology in an era of increasing antibiotic resistance and high mortality associated with sepsis and consider the application of this as a possible treatment option for COVID-19.
MeSH term(s)	Anticoagulants/chemistry ; Bacteria/isolation & purification ; Bacterial Infections/blood ; Bacterial Infections/therapy ; Binding Sites ; COVID-19/blood ; COVID-19/therapy ; Hemoperfusion/methods ; Heparin/chemistry ; Humans ; SARS-CoV-2/isolation & purification
Chemical Substances	Anticoagulants ; Heparin (9005-49-6)
Keywords	covid19
Language	English
Publishing date	2020-07-02
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	605548-5
ISSN	1421-9735 ; 0253-5068
ISSN (online)	1421-9735
ISSN	0253-5068
DOI	10.1159/000508647
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Article: In vitro

Schmidt, Julius J / Eden, Gabriele / Seffer, Malin-Theres / Winkler, Manuela / Kielstein, Jan T

Clinical kidney journal

2020 Volume 13, Issue 3, Page(s) 421–424

Abstract: Background: In August 2019, the European Union licensed the first ever haemoperfusion device aimed to reduce pathogens in the blood. The core of the adsorber consists of ultra-high molecular weight polyethylene beads with endpoint-attached heparin. ... ...

Abstract	Background: In August 2019, the European Union licensed the first ever haemoperfusion device aimed to reduce pathogens in the blood. The core of the adsorber consists of ultra-high molecular weight polyethylene beads with endpoint-attached heparin. These beads utilize pathogen inherent adhesion mechanisms to reduce pathogen load. So far, it is unknown whether the device has an effect on anti-infective drug concentrations. The aim of this study was to investigate the Methods: In this Results: We found a reduction ratio (RR) in anti-infective plasma levels between -1% and 62%. This decrease occurred mainly in the first 5 min of the experiment (RR Conclusions: The elimination of anti-infective drugs by the Seraph is neglectable in all but 2 of 18 of the investigated substances. Aminoglycosides may be adsorbed by the device during their first pass.
Language	English
Publishing date	2020-05-21
Publishing country	England
Document type	Journal Article
ZDB-ID	2655800-2
ISSN	2048-8513 ; 2048-8505
ISSN (online)	2048-8513
ISSN	2048-8505
DOI	10.1093/ckj/sfaa063
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Article: Heparin 2.0: A New Approach to the Infection Crisis

Seffer, Malin-Theres / Cottam, Daniel / Forni, Lui G / Kielstein, Jan T

Blood Purif

Abstract	In April 2020, the US Food and Drug Administration granted emergency use authorization for certain medical devices to be used in patients with coronavirus disease 2019 (CO-VID-19). This included extracorporeal blood purification devices. This narrative review will give a brief overview regarding some of the extracorporeal devices that could be used to treat COVID-19 patients, including the Seraph® 100 Microbind® Affinity Blood Filter, produced by ExThera Medical (Martinez, CA, USA), first licensed in the European Economic Area in 2019. The Seraph® 100 contains ultrahigh molecular weight polyethylene beads with end point-attached heparin and is approved for the reduction of pathogens from the bloodstream either as a single agent or as an adjunct to conventional anti-infective agents. Bacteria, viruses, fungi, and toxins have been shown to bind to the immobilized heparin in a similar way to the interaction with heparan sulfate on the cell surface. This binding is nonreversible and as such, the pathogens are removed from the bloodstream. In this review, we describe the pathophysiological basis and rationale for using heparin for pathogen removal from the blood as well as exploring the technology behind the adaptation of heparin to deprive it of its systemic anticoagulant activity. In addition, we summarize the in vitro data as well as the available preclinical testing and published clinical reports. Finally, we discuss the enormous potential of this technology in an era of increasing antibiotic resistance and high mortality associated with sepsis and consider the application of this as a possible treatment option for COVID-19.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #624949
Database	COVID19

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Book ; Online: Heparin 2.0

Seffer, Malin-Theres / Cottam, Daniel / Forni, Lui G / Kielstein, Jan T

1 ; 7 ; Blood purification ; Switzerland

A New Approach to the Infection Crisis.

2020

Abstract	In April 2020, the US Food and Drug Administration granted emergency use authorization for certain medical devices to be used in patients with coronavirus disease 2019 (CO-VID-19). This included extracorporeal blood purification devices. This narrative review will give a brief overview regarding some of the extracorporeal devices that could be used to treat COVID-19 patients, including the Seraph® 100 Microbind® Affinity Blood Filter, produced by ExThera Medical (Martinez, CA, USA), first licensed in the European Economic Area in 2019. The Seraph® 100 contains ultrahigh molecular weight polyethylene beads with end point-attached heparin and is approved for the reduction of pathogens from the bloodstream either as a single agent or as an adjunct to conventional anti-infective agents. Bacteria, viruses, fungi, and toxins have been shown to bind to the immobilized heparin in a similar way to the interaction with heparan sulfate on the cell surface. This binding is nonreversible and as such, the pathogens are removed from the bloodstream. In this review, we describe the pathophysiological basis and rationale for using heparin for pathogen removal from the blood as well as exploring the technology behind the adaptation of heparin to deprive it of its systemic anticoagulant activity. In addition, we summarize the in vitro data as well as the available preclinical testing and published clinical reports. Finally, we discuss the enormous potential of this technology in an era of increasing antibiotic resistance and high mortality associated with sepsis and consider the application of this as a possible treatment option for COVID-19.
Keywords	Antibiotic resistance ; Blood purification ; Extracorporeal therapy ; covid19
Subject code	610
Language	English
Publishing date	2020-07-02
Publisher	Karger AG
Publishing country	de
Document type	Book ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Clearance of chloroquine and hydroxychloroquine by the Seraph® 100 Microbinda Affinity Blood Filter -a device approved for the treatment of COVID-19 patients.

Seffer, Malin-Theres / Martens-Lobenhoffer, Jens / Schmidt, Julius J / Eden, Gabriele / Bode-Böger, Stefanie M / Kielstein, Jan T

Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy

2020 Volume 25, Issue 2, Page(s) 237–241

Abstract: On April 17 2020, the United States Food and Drug Administration granted Coronavirus Disease 2019 (COVID-19) emergency use authorizations for the Seraph 100 Microbind Affinity Blood Filter. The medical device is aimed to treat critically ill COVID-19 ... ...

Abstract	On April 17 2020, the United States Food and Drug Administration granted Coronavirus Disease 2019 (COVID-19) emergency use authorizations for the Seraph 100 Microbind Affinity Blood Filter. The medical device is aimed to treat critically ill COVID-19 patients with confirmed or imminent respiratory failure. The aim of this life size in vitro pharmacokinetic study was to investigate the in vitro adsorption of chloroquine and hydroxychloroquine from human plasma using equipment that is also used at the bedside. After start of the hemoperfusion, Pre (C
MeSH term(s)	COVID-19/drug therapy ; Chloroquine/pharmacokinetics ; Chromatography, High Pressure Liquid ; Hemofiltration ; Hemoperfusion ; Humans ; Hydroxychloroquine/pharmacokinetics ; In Vitro Techniques
Chemical Substances	Hydroxychloroquine (4QWG6N8QKH) ; Chloroquine (886U3H6UFF)
Keywords	covid19
Language	English
Publishing date	2020-07-28
Publishing country	Australia
Document type	Journal Article
ZDB-ID	2119809-3
ISSN	1744-9987 ; 1091-6660 ; 1744-9979
ISSN (online)	1744-9987
ISSN	1091-6660 ; 1744-9979
DOI	10.1111/1744-9987.13549
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