An In Vitro Pilot Study Comparing the Novel HemoClear Gravity-Driven Microfiltration Cell Salvage System with the Conventional Centrifugal XTRA™ Autotransfusion Device

Hoetink, Anneloes; Scherphof, Sabine; Mooi, Frederik J; Westers, Paul; Dijk, Jack van; Leur, Sjef J van de; Nierich, Arno P.

doi:10.1155/2020/9584186

Cited by 7 publications

(8 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Convalescent plasma was obtained via plasmapheresis using HemoClear blood filters (HemoClear BV, Zwolle, The Netherlands) [14]. In this method, whole blood is separated via gravity-based sterile filtering through a multi-layered cross-flow membrane module [15]. This offers a high yield of CP without loss of RBCs and was the only available plasmapheresis method.…”

Section: Plasma Preparation Procedures and Quality Controlmentioning

confidence: 99%

“…Furthermore, the optimal volume of CP for infusion as well as safety of blood donation for a CP donor were unknown. In this study, we made use of a gravity-driven blood filter for CP production, called the HemoClear device [8]. To be able to identify short-term treatment effects in the absence of extensive laboratory diagnostic capacity, changes in oxygen balance and chest x-ray score (CXR) were assessed 2 days after CP therapy.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Mortality Reduction in ICU-Admitted COVID-19 Patients in Suriname after Treatment with Convalescent Plasma Acquired Via Gravity Filtration

Bihariesingh¹,

Bansie²,

Fröberg³

et al. 2021

ACR

View full text Add to dashboard Cite

Introduction: Although convalescent plasma (CP) treatment is a potential therapeutic option for patients with COVID-19, there is a paucity of data from intensive care unit (ICU) patients with COVID-19 in low-resource settings, such as Suriname. CP was produced by a novel gravity-based filtration method. Methods: In an open-label, multi-center, non-randomized prospective clinical trial, patients with severe or life- threatening COVID-19 symptoms (n=28) with CP treatment were compared with standard treatment alone (n=50). A pre-planned interim analysis is reported. The primary endpoint was a 28-day ICU mortality. Secondary endpoints were changes two days after treatment initiation in pulmonary oxygen exchange capacity (PF ratio) and chest x-ray (CXR) score. Results: Mortality occurred in 18% (CP: 5/28) vs. 36% (Control:18/50). CP treatment of severe COVID-19 resulted in a higher probability of survival, with a hazard ratio (HR) of 0.22 (95% CI, 0.074-0.067), correcting for age, the presence of diabetes and COVID-19 severity. In the severe group, CP resulted in an improved CXR score (P = 0.0013) and increase in PF ratio (P = 0.011) as compared to standard therapy. The gravity-based plasmapheresis method used for CP production was well-tolerated and no adverse events were observed in the donors. Discussion: CP therapy in combination with standard treatment resulted in 78% reduction of 28-day ICU mortality (HR = 0.22) compared to standard treatment alone. Both CXR-score and PF ratio changes represent effective indicators for the treatment effect of CP after two days. The novel CP production method was effective and represents a practical solution for Low- and middle-income countries to produce CP.

show abstract

Section: Plasma Preparation Procedures and Quality Controlmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Mortality Reduction in ICU-Admitted COVID-19 Patients in Suriname after Treatment with Convalescent Plasma Acquired Via Gravity Filtration

Bihariesingh¹,

Bansie²,

Fröberg³

et al. 2021

ACR

View full text Add to dashboard Cite

show abstract

“…Furthermore, the optimal volume of CP for infusion as well as safety of blooddonation for a CP donor were unknown. In this study, we made use of a gravity-driven blood filter for CP production, called the HemoClear device 8 . To be able to identify short-term treatment effects in the absence of extensive laboratory diagnostic capacity, changes in oxygen balance and chest x-ray score (CXR) were assessed 2 days after CP therapy.…”

Section: Introductionmentioning

confidence: 99%

Mortality reduction in ICU-admitted COVID-19 patients in Suriname after treatment with convalescent plasma acquired via gravity filtration

Bihariesingh

Bansie

Fröberg

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

Background Although convalescent plasma (CP) treatment is a potential therapeutic option for patients with COVID-19, there is a paucity of data from studies in low-resource settings. The efficacy and safety of CP therapy in intensive care unit (ICU) patients with COVID-19 in Suriname was evaluated. A novel gravity-based filtration method was used to obtain CP. The design was an open-label, multi-centre, non-randomized prospective clinical trial performed in two hospitals in Suriname, from June 2020, to December 2020. A pre-planned interim analysis is reported in 78 PCR-confirmed COVID-19 patients admitted to the ICU with severe or lifethreatening symptoms. CP in combination with standard treatment (n = 28) was compared to standard treatment alone (control) (n = 50), stratified by disease severity. The primary endpoint was 28-day ICU mortality. Secondary (exploratory) endpoints were changes two days after treatment initiation in pulmonary oxygen exchange capacity (PF ratio) and chest xray (CXR) score. Findings The median age of patients was 52 years with 43 [55.1%] being male. Twenty-eight day mortality occurred in 18% (5/28) of the CP group vs 36% (18/50) of the control group. Survival probability was significantly higher in the CP group compared to the control group with standard care (P=0.027). When stratifying into disease severity, the survival probability was the lowest for the control group with life-threatening disease (P=0.0051). CP treatment of severe COVID-19 resulted in a higher probability of survival, with a hazard ratio (HR) of 0.22 (95% CI, 0.074-0.067), correcting for age, the presence of diabetes and COVID-19 severity. Age significantly increased the mortality risk (HR, 1.08 [95%CI, 1.022-1.14]; P =0.006). In the severe group, CP resulted in an improved CXR score (P =0.0013) and increase in PF ratio (P = 0.011) as compared to standard therapy. The gravity-based plasmapheresis method used for CP production was well-tolerated and no adverse events were observed in the donors. Interpretation Among patients with severe or life-threatening COVID-19, CP therapy in combination with standard treatment resulted in 78% reduction of 28-day ICU mortality (HR = 0.22) compared to standard treatment alone. Both CXR-score and PF ratio changes represent indicators of treatment effect of CP after two days and can easily be implemented in low-resource settings. The novel CP production method was effective and represents a practical solution for low and middle income countries (LMICs) to produce CP locally. Although interpretation is limited by the non-randomised design of the trial, these results offer a potential route for broader implementation of CP treatment in LMICs.

show abstract

“…As for the diameter of the filter pores for the re-transfusion of recovered blood, 40 to 100 microns have been traditionally recommended. A recent study [17] has evaluated the efficacy of cell washing and recovery by measuring complete blood count, free haemoglobin, complement factors and D-dimer in both concentrated and filtered blood. The best device achieved a significantly higher reduction of contaminants.…”

Section: Introductionmentioning

confidence: 99%

Cell Salvage in Oncological Surgery, Peripartum Haemorrhage and Trauma

2022

View full text Add to dashboard Cite

Oncological surgery, obstetric haemorrhage and severe trauma are the most challenging conditions for establishing clinical recommendations for the use of cell salvage. When the likelihood of allogeneic transfusion is high, the intraoperative use of this blood-saving technique would be justified, but specific patient selection criteria are needed. The main concerns in the case of oncological surgery are the reinfusion of tumour cells, thereby increasing the risk of metastasis. This threat could be minimized, which may help to rationalize its indication. In severe peripartum haemorrhage, cell salvage has not proven cost-effective, damage control techniques have been developed, and, given the risk of fetomaternal alloimmunization and amniotic fluid embolism, it is increasingly out of use. In trauma, bleeding may originate from multiple sites, coagulopathy may develop, and it should be evaluated whether re-transfusion of autologous blood collected from uncontaminated organ cavities would be feasible. General safety measures include washing recovered blood and its passage through leukocyte depletion filters. To date, no well-defined indications for cell salvage have been established for these pathologies, but with accurate case selection and selective implementation, it could become safe and effective. Randomized clinical trials are urgently needed.

show abstract

An In Vitro Pilot Study Comparing the Novel HemoClear Gravity-Driven Microfiltration Cell Salvage System with the Conventional Centrifugal XTRA™ Autotransfusion Device

Cited by 7 publications

References 27 publications

Mortality Reduction in ICU-Admitted COVID-19 Patients in Suriname after Treatment with Convalescent Plasma Acquired Via Gravity Filtration

Mortality Reduction in ICU-Admitted COVID-19 Patients in Suriname after Treatment with Convalescent Plasma Acquired Via Gravity Filtration

Mortality reduction in ICU-admitted COVID-19 patients in Suriname after treatment with convalescent plasma acquired via gravity filtration

Cell Salvage in Oncological Surgery, Peripartum Haemorrhage and Trauma

Contact Info

Product

Resources

About