Use of Accessible Blood Filter for Post-operative Cell Salvage in Cardiac Surgery

The availability of centrifugal cell savers supports intraoperative cell salvage and thereby reduces the need for allogeneic red blood cell transfusion. Use of these devices, however, is limited to the operating room, forcing a switch to allogeneic products in the post-operative setting. Here we present a case of massive post-operative bleeding due to severe coagulopathy following CABG. Due to the lack of availability of donor blood products a novel blood filter (HemoClear BV, Zwolle, the Netherlands) was used for post-operative salvage. Because of its accessible use, we believe this salvage device has great clinical value in the poor-resource setting.

Two Patients With Severe COVID Pneumonia Treated With the Seraph-100 Microbind Affinity Blood Filter

We present 2 patients with rapidly escalating oxygen requirements from severe acute respiratory syndrome coronavirus 2 infection (COVID-19) treated with the Seraph100 Microbind Affinity Blood Filter under Emergency Use Authorization from the US Federal Drug Administration. The Seraph100 is an extracorporeal hemoperfusion filter previously demonstrated to remove viral particles and pro-inflammatory cytokines from the blood. Treatment with the Seraph100 filter was associated with a rapid improvement in oxygenation and both patients were discharged from the hospital without supplemental oxygen.

Seraph-100 Hemoperfusion in SARS-CoV-2-Infected Patients Early in Critical Illness: A Case Series

There is an urgent need for therapeutic interventions to alter the course of critically ill coronavirus disease 2019 (CO­VID-19) patients. We report our experience with the Seraph-100 Microbind Affinity Blood Filter (Seraph-100) in 4 patients with COVID-19 early in the course of their critical respiratory illnesses. Patients were diagnosed with COVID-19 and were admitted to intensive care with worsening respiratory failure but did not require dialysis or vasopressors. Patients had to have a PaO₂ to FiO₂ (P/F ratio) <150 to qualify for hemoperfusion therapy. All patients received standard medical therapy including oral vitamins C and D and zinc in addition to intravenous dexamethasone and remdesivir. Patients received a single 5- to 7-h session with Seraph-100 on a conventional dialysis machine (Fresenius 2008T) via a nontunneled central venous dialysis catheter with a goal of processing at least 100 L of blood. Patients received weight-based subcutaneous enoxaparin anticoagulation, as well as systemic intravenous heparin (70 units/kg), just prior to hemofiltration. Treatment with Seraph-100 hemoperfusion was well tolerated, and all patients were able to finish their prescribed therapy. All patients treated with Seraph-100 survived to be discharged from the hospital. Well-designed clinical trials are needed to determine the overall safety and efficacy of the Seraph-100 Microbind Affinity Blood Filter in COVID-19 patients.

Interim-analysis of the COSA (COVID-19 Patients Treated With the Seraph® 100 Microbind® Affinity Filter) Registry

Background: The Seraph®100 Microbind Affinity Blood Filter® is a hemofiltration device that is licensed for pathogen reduction in the blood. This includes several viruses. Removal of the nucleocapsid of the SARS-CoV-2 virus by the Seraph®100 has been recently demonstrated. As viral load has repeatedly been shown to correlate with adverse outcome in severe coronavirus disease 2019 (COVID-19), the aim of this registry was to evaluate safety and efficacy of Seraph®100 treatment for COVID-19.Methods: An online registry in which main patient charcteristics, treatment coordinates and outcome parameters was documented without reimbursement. So far 12 hospitals in 4 countries on 2 continents took part in the registry. 75 treatment sessions in 60 patients were documented in the registry. Results: Adverse effects of the Seraph® 100 treatment were reported in 2 (2.6 %) of the 75 treatments. Eight (10.6 %) of all the procedures ended prematurely due to circuit failure / clotting. Half of the treatments (47.6 %) were performed as hemoperfusion only. 21.6 % of the treatments were performed in conjuction with intermittent hemodialysis. Median treatment time was 4.21 [4.00 - 8.06] h. Anticoagulation was performed using citrate in 20.6 % of treatments. Patients that died despite treatment with the Seraph® 100 filter had a higher rate of bacterial superinfection, higher level of inflammatory laboratory markers (procalcitonin and ferritin) and higher d-dimer levels. While predicted survival rate in ICU patients was >80 %, the observed survival rate was 47.6 %. In non-ICU patients, 4 C score predicted a survival rate of 31.4-34.9 % while the observed survival rate was 22.2 %.Conclusion: Seraph® 100 treatment was well tolerated and circuit failure rate was significantly lower than reported for KRT in COVID-19 patients. All patients that died despite of Seraph® 100 treatment had serious pre-existing medical conditions, coexisting bacterial infections and more pronounced systemic signs of inflammation. Compared to the calculated mortality using established scores, the observed mortality in the Seraph® 100 treated patients was lower.Trial registration:ClinicalTrials.gov Identifier: NCT04361500

A Multicenter Evaluation of Blood Purification with Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19: A Preliminary Report

ObjectiveThe Seraph®100 Microbind Affinity Blood Filter® (Seraph 100) is an extracorporeal medical countermeasure that can remove many pathogens from blood, including the SARS-CoV-2 virus. The aim of this study was to evaluate safety and efficacy of Seraph 100 treatment for severe coronavirus disease 2019 (COVID-19).DesignMulticenter retrospective observational cohort study.SettingIntensive care units across four of thirteen participating sites who have completed data extraction.PatientsCritically ill COVID-19 patients treated with Seraph 100 under an Emergency Use Authorization (n=53) and historical control patients who met criteria for treatment (n=46).InterventionExtracorporeal treatment with the Seraph 100 filter.Measurements and Main ResultsAt baseline, the median age was 61 years, 72.7% were male, and 59.6% required mechanical ventilation. The groups were matched in terms of sex, race/ethnicity, body mass index, APACHE II score, need for mechanical ventilation, and other COVID-19 treatments. However, patients in the Seraph 100 group were younger with a median age of 61 years (IQR 42-65) compared to controls who had a median age of 64 (IQR 56-68, p=0.036). The Seraph 100 group also had a lower median Charlson comorbidity index (2, IQR 0-3) compared to control patients (3, IQR 2-4, p=0.006). Mortality was lower in the Seraph 100 treated group compared to the historical controls (37.7% vs 67.4%, respectively, p=0.003). Multivariable logistic regression analysis yielded an odds ratio of 0.27 (95% confidence interval 0.09-0.79, p=0.016). Of the 53 patients treated with Seraph 100, only 1 patient experienced a serious adverse event (transient hypotension at the start of the treatment which required a brief period of vasopressor support).ConclusionsThese data suggest that broad spectrum, pathogen agnostic, extracorporeal blood purification technologies can be safely and effectively deployed to meet new pathogen threats as an adjunct to standard treatments while awaiting the development of directed pharmacologic therapies and/or vaccines.

Elimination of Staphylococcus aureus from the bloodstream using a novel biomimetic sorbent haemoperfusion device

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.