Clinical studies with solvent detergent-treated products

Pehta, Joan C.

doi:10.1016/s0887-7963(96)80006-x

Cited by 33 publications

(33 citation statements)

References 28 publications

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“…The risk of transfusion‐associated viral and bacterial disease continues to be a major concern in transfusion medicine. Although albumin, immune globulin, factor concentrates, and other plasma derivatives are virally attenuated following standard preparative protocols, plasma components like fresh‐frozen plasma (FFP) still have a risk of virus transmission similar to that of whole blood 1,2 . There are no currently available Food and Drug Administration‐licensed methods for removing or inactivating infectious agents in cellular blood components, including red cells (RBCs) and platelets.…”

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confidence: 99%

Effects of methylene blue‐treated plasma on red cells and stored platelet concentrates

et al. 1999

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confidence: 99%

Effects of methylene blue‐treated plasma on red cells and stored platelet concentrates

et al. 1999

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“…[12][13][14][15][16] In part due to its cost, and in part due to the lack of availability of virally inactivated RBC and platelet units, SD plasma is not used in the United States. [12][13][14][15][16] In part due to its cost, and in part due to the lack of availability of virally inactivated RBC and platelet units, SD plasma is not used in the United States.…”

Section: Chapter 19mentioning

confidence: 99%

“…Although SD plasma is a pooled product and may contain parvovirus B19 and hepatitis A virus, it also contains neutralizing antibody to these viruses, which may modify the risk of infectivity or its clinical significance. [12][13][14][15][16] In the United Kingdom, it is recommended that the FFP given to neonates and children should be obtained from an area free of bovine spongiform encephalopathy (BSE) and be subjected to pathogen-reduction procedures. 152,153 Other methods to reduce or inactivate pathogens in FFP have been developed.…”

Section: Infectious Potentialmentioning

confidence: 99%

Fresh Frozen Plasma and Related Products

Crookes¹,

Hillyer²

2007

Blood Banking and Transfusion Medicine

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“…While prospective trials with previously unexposed patients show no transmission of HIV, HCV and HBV in patients treated with solvent/detergent‐treated, pasteurized and severely (80 °C/72 h) dry‐heated concentrates [20], one study suggests that pasteurization may allow transmission of HBV [22]. The unchallenged position of solvent/detergent‐treated concentrates in terms of safety to the highly pathogenic enveloped TTVs [23], makes this technology practically mandatory in the manufacture of factor concentrates. The inherent inability of this method to inactivate nonenveloped viruses supports current regulatory strategies that recommend the use of two viral elimination steps, for both enveloped and nonenveloped viruses [24].…”

Section: Viral Elimination Procedures In 2002mentioning

confidence: 99%

“…Data on the physical properties of this agent and its incidence in the haemophilia population are currently unavailable, but the virus is nonenveloped and thus not susceptible to solvent/detergent treatment. Although early studies had indicated that hepatitis was transmitted through concentrates solely by enveloped viruses [32], the transmission of the nonenveloped hepatitis A (HAV) virus through solvent/detergent‐treated factor concentrates [23] mandates caution in assessing the possible impact of SEN‐V and other potential hepatitis agents and reinforces the need for more universal viral elimination procedures.…”

Section: Emerging Infectious Agents: Virusesmentioning

confidence: 99%

Evolving perspectives in product safety for haemophilia

Farrugia¹

2002

Haemophilia

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The past decade has seen a consolidation of the safety measures built into the manufacture of coagulation factor concentrates for people with haemophilia. The scientific developments of the 1980s have been fully reflected in the manufacturing principles and the regulatory control of concentrate production, so that the safety of concentrate therapy now exceeds the safety of normal blood transfusion. A clear understanding of the epidemiology of the transfusion-transmitted viruses allows the selection of donors with a satisfactory safety profile. Source material for plasma-derived concentrates is now screened with sensitive tests that detect viral infection in donors at a very early phase in the viral life cycle. This decreases the potential viral load to levels that are easily eliminated by well-accredited viral inactivation procedures. These measures have ensured a high level of assurance regarding the safety of products from the traditional transfusion-transmitted infections. However, testing for some transfusion-transmitted viruses does not yet form part of mainstream blood screening; alternative strategies based upon the particular needs of pooled plasma product recipients may be more feasible. Whereas the risk of emerging pathogens has to be kept constantly under review, four such viruses identified over the 1990s have proven to be of little relevance to plasma product recipients and the need for measures specifically directed against them is debatable. The risk of variant Creuzfeldt-Jakob Disease (vCJD) is a special case of an emerging infection that is insufficiently well characterized to allow a conclusive assessment of its role in the safety of concentrates; however, data regarding the capacity of concentrate manufacturing methods to clear the putative agent are encouraging. The relative uncertainty surrounding vCJD has caused the influential regulatory authorities of North America to take a precautionary approach regarding the selection of blood donors. This is having an effect on the supply of factor VIII concentrates and has possibly affected the rate at which developed countries have switched to recombinant products. The safety of recombinant products continues to be supported through patient monitoring, and the new generation of plasma protein-free products will further enhance the role of these products as the treatment of choice with people with haemophilia. However, their cost-effectiveness relative to the current generation of plasma-derived products makes it unlikely that they will be accessible by developing countries. The dependence of most of the world's population of people with haemophilia on a safe and sufficient blood supply will therefore continue into the foreseeable future, and with it the need to maintain constant vigilance on blood safety matters.

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Clinical studies with solvent detergent-treated products

Cited by 33 publications

References 28 publications

Effects of methylene blue‐treated plasma on red cells and stored platelet concentrates

Effects of methylene blue‐treated plasma on red cells and stored platelet concentrates

Fresh Frozen Plasma and Related Products

Evolving perspectives in product safety for haemophilia

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