Solvent/detergent-treated plasma: composition, efficacy, and safety

Hellstern, Peter

doi:10.1097/01.moh.0000137915.88478.23

Cited by 84 publications

(95 citation statements)

References 24 publications

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“…In order to decrease the content of protein S there is an increased risk for thrombosis [37] or hyperfibrinolysis may be augmented due to a decreased content of α 2 -AP [38]. Approximately 30% of the fibrinogen is also affected and destroyed [39] during methylene blue pathogen inactivation, which results in reduced fibrin polymerization and again impairs the efficacy of FFP.…”

Section: Management Of Hepatic Coagulopathymentioning

confidence: 99%

Delicate Balance of Bleeding and Thrombosis in End-Stage Liver Disease and Liver Transplantation

Saner

Gieseler²,

Akız³

et al. 2013

Digestion

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Liver transplantation in cirrhotic patients is accompanied by severe bleeding. Indeed, the first 100 recipients of liver allografts transplanted by Thomas E. Starzl died mainly by uncontrolled bleeding. Since then, much progress has been made as to the understanding of the pathophysiology and the treatment of hemostatic disorders in cirrhotic patients. The aim of this review is to provide a state-of-the-art overview on recent developments and treatment options for hemostatic disorder in cirrhotic patients. Patients with end-stage-liver disease (ESLD) do not suffer only from procoagulant deficiency; there is also a lack of natural anticoagulants (i.e. proteins C and S) and profibrinolytics. Conventional laboratory methods such as the determination of the international normalized ratio or the activated partial thromboplastin time cannot predict bleeding complications in these patients. Progressive diagnostic techniques reveal that cirrhotic patients have the same capacity to produce thrombin like healthy volunteers. Moreover, cirrhotic patients - and particularly those with primary biliary cirrhosis or primary sclerosing cholangitis - are at a higher risk for developing thrombosis as compared with healthy controls. Hemostatic alterations are common in cirrhotic patients; they involve both the pro- and the anticoagulant pathways. However, this is a very delicate balance, which may be shifted to either of these pathways by different treatments thereby causing bleeding or thrombosis, respectively.

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Section: Management Of Hepatic Coagulopathymentioning

confidence: 99%

Delicate Balance of Bleeding and Thrombosis in End-Stage Liver Disease and Liver Transplantation

Saner

Gieseler²,

Akız³

et al. 2013

Digestion

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show abstract

“…The observed safety of Uniplas, with respect to fibrinolysis and thromboembolism, is in accordance with experience with Octaplas. 15 In Europe, a retrospective study has raised concerns about venous thromboembolism in patients with thrombotic thrombocytopenic purpura who had plasma exchange with Octaplas. 27 This could be attributed to the fact that protein S is reduced to the lower normal range in Octaplas and Uniplas.…”

Section: Discussionmentioning

confidence: 99%

“…In spite of the fact that both products are SD-treated by similar methods, significant product differences, ascribed to production methods and type of plasma used, have been reported. 13,14,15 Such differences could explain the complications observed in the US. 15 In Europe, three prospective, randomized and three observational studies have demonstrated a similar clinical efficacy of SD-treated plasma and fresh-frozen single donor plasma in various clinical settings.…”

mentioning

confidence: 99%

“…13,14,15 Such differences could explain the complications observed in the US. 15 In Europe, three prospective, randomized and three observational studies have demonstrated a similar clinical efficacy of SD-treated plasma and fresh-frozen single donor plasma in various clinical settings. 16 Although the clinical studies included only 376 patients, and therefore lacked the statistical power to detect minor differences, the results demonstrate that reductions in coagulation factor and inhibitor levels caused by SD treatment did not impair clinical efficacy.…”

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confidence: 99%

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Universal Pathogen-Reduced Plasma in Elective Open-Heart Surgery and Liver Resection

Solheim

2006

Clinical Medicine & Research

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ABO-incompatible transfusions and transfusion-related lung injury are today the leading transfusion-related causes of death in the developed world. Since anti-A and anti-B antibodies in plasma can give rise to serious, even fatal, transfusion reactions,ABO-identical/compatible plasma is indicated, but presents a logistical challenge and a risk for transfusion of incorrect plasma. In an effort to circumvent these problems, an ABO-independent universally applicable, pathogen-reduced plasma, Uniplas, has been developed and proven safe and efficacious for use in adults through prospective, randomized, controlled open-heart surgery studies and in prospective, parallel group, controlled liver resection studies.The results of these trials are presented and discussed in relation to solvent/detergent (SD) treated plasma, in general.The cost effectiveness of pathogen-reduced plasma is low because of the very low risk for transfusion transmitted viral infections in the developed world (US $2 to $9 million per quality-adjusted life year). However, taking into account the combined safety of Uniplas with regard to transfusion-related lung injury, pathogen reduction and independence of ABO blood groups, the cost per gained life year is reduced to US $40,000 to $100,000.

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“…However, S/D can't inactivate non-enveloped virus, such as hepatitis A virus (HAV) and parvovirus B19. Various studies [5][6][7] showed that treatment of S/D could reduce the activity of coagulation factors (CFs), inhibitors, immunoglobulins and other plasma proteins by about 5-20%. S/D treatment is safe and the final S/D reagents removal step ensures the final product is non toxic.…”

Section: Pi/pr By Solvent/detergent (S/d)mentioning

confidence: 99%

Last Line to Secure Transfusion Safety: Pathogen Inactivation/Reduction Methods in Blood Products-Current Approaches and Perspectives

Yang¹,

Zeng²,

Li³

et al. 2013

J Antivir Antiretrovir

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Solvent/detergent-treated plasma: composition, efficacy, and safety

Cited by 84 publications

References 24 publications

Delicate Balance of Bleeding and Thrombosis in End-Stage Liver Disease and Liver Transplantation

Delicate Balance of Bleeding and Thrombosis in End-Stage Liver Disease and Liver Transplantation

Universal Pathogen-Reduced Plasma in Elective Open-Heart Surgery and Liver Resection

Last Line to Secure Transfusion Safety: Pathogen Inactivation/Reduction Methods in Blood Products-Current Approaches and Perspectives

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