Universal fresh frozen plasma (Uniplas): a safe product in open-heart surgery

Töllöfsrud, Stein; Noddeland, Harald; Svennevig, Jan; Bentsen, Gunnar; Mollnes, Tom Eirik; Solheim, Bjarte G.

doi:10.1007/s00134-003-1952-3

Cited by 29 publications

(27 citation statements)

References 20 publications

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“…No fewer than 18 recently reviewed studies and retrospective analyses covering all indications for plasma have been conducted to examine the efficacy and tolerance of SD plasma [10], two of them examining the use of universal SD plasma (Uniplas) in open-heart surgery and in adults undergoing elective liver resection [34,35]. Though all of these studies lacked statistical power to detect minor differences due to their small size, they clearly show that the loss of coagulation factor and inhibitor levels caused by SD treatment does not result in any significant loss of clinical efficacy or tolerance.…”

Section: Clinical Studies and Experience With Sd Plasmamentioning

confidence: 99%

The Use of Solvent/Detergent Treatment in Pathogen Reduction of Plasma

Hellstern

Solheim

2011

Transfus Med Hemother

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118

147

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SummaryThe solvent/detergent (SD) process used for plasma can safely inactivate all lipid-enveloped viruses. The introduction of a specific prion-binding ligand gel in combination with SD treatment, time-reduced from 4 to 1-1.5 h, still ensures efficient virus kill, reduces abnormal prion protein by >5 log steps, and preserves levels of plasmin inhibitor at close to the reference range. Infections with known nonenveloped viruses such as HAV or parvovirus B19 are prevented by ensuring low virus loads in the starting plasma units, dilution through pooling of single plasma units, and neutralization of immune antibodies already present in the initial plasma pools. The major advantages of SD plasma over fresh frozen plasma and the other pathogen-inactivated plasmas are its extreme safety with respect to transfusion-related acute lung injury and the significantly lower likelihood of provoking allergic reactions. Both advantages are best interpreted as results of the dilution effect of pooling. No fewer than 18 clinical studies covering all indications for plasma, and extensive clinical experience have shown that reduced levels of coagulation factors and inhibitors as a result of SD treatment do not impair significantly the clinical efficacy or tolerance of plasma. Properly standardized clotting factor and inhibitor potencies and low batch-to-batch variations when compared with single-donor plasma units makes SD plasma more suitable for standardized treatment. Schlüsselwörter

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Section: Clinical Studies and Experience With Sd Plasmamentioning

confidence: 99%

The Use of Solvent/Detergent Treatment in Pathogen Reduction of Plasma

Hellstern

Solheim

2011

Transfus Med Hemother

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118

147

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“…These results were in agreement with the previous findings from a randomized clinical trial conducted by Wieding et al [77] comparing S/D plasma and MB light virus-inactivated plasma in 71 patients undergoing cardiopulmonary bypass surgery. A prospective randomized study by Tollofrsud et al [78] also reported positive experience on the use of S/D plasma in open-heart surgery. Finally, on the basis of the finding that S/D plasma lacks the highest molecular weight vWF multimers [56], which have been involved in the pathogenesis of TTP, some investigators have assessed S/D plasma in the treatment of patients with acute TTP with reported rates of remission between 90 and 100 % [43, [79][80][81][82].…”

Section: Efficacy Issuesmentioning

confidence: 99%

Solvent/detergent plasma: pharmaceutical characteristics and clinical experience

Liumbruno

Franchini

2014

J Thromb Thrombolysis

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The solvent/detergent treatment is an established virus inactivation technology that has been industrially applied for manufacturing plasma derived medicinal products for almost 30 years. Solvent/detergent plasma is a pharmaceutical product with standardised content of clotting factors, devoid of antibodies implicated in transfusion-related acute lung injury pathogenesis, and with a very high level of decontamination from transfusion-transmissible infectious agents. Many clinical studies have confirmed its safety and efficacy in the setting of congenital as well as acquired bleeding disorders. This narrative review will focus on the pharmaceutical characteristics of solvent/detergent plasma and the clinical experience with this blood product.

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“…In a published study, no patients seroconverted to HIV, HTLV, HBC, CMV, HAV, or parvovirus B19 seropositivity. 48 Two studies showed equivalent efficacy of Uniplas w with Octiplas w in open-heart surgeries 48,49 , although Uniplas w has the additional benefit of being compatible with all blood groups. Further studies are recommended to determine if Uniplas w is otherwise equivalent to standard SD.…”

Section: Present Researchmentioning

confidence: 99%

“…Further studies are recommended to determine if Uniplas w is otherwise equivalent to standard SD. 48,49 Phenothiazinium dyes: methylene blue Methylene blue (MB) was first synthesized by Caro in 1876; in 1883 Bernsthen synthesized the parent ring system. Currently, this compound has been administered orally as an antiseptic, disinfectant, and an antidote for nitrate poisoning.…”

Section: Present Researchmentioning

confidence: 99%

Pathogen inactivation techniques

Pelletier¹,

Transue²,

Snyder

2006

Best Practice & Research Clinical Haematology

111

106

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The desire to rid the blood supply of pathogens of all types has led to the development of many technologies aimed at the same goal--eradication of the pathogen(s) without harming the blood cells or generating toxic chemical agents. This is a very ambitious goal, and one that has yet to be achieved. One approach is to shun the 'one size fits all' concept and to target pathogen-reduction agents at the Individual component types. This permits the development of technologies that might be compatible with, for example, plasma products but that would be cytocidal and thus incompatible with platelet concentrates or red blood cell units. The technologies to be discussed include solvent detergent and methylene blue treatments--designed to inactivate plasma components and derivatives; psoralens (S-59--amotosalen) designed to pathogen-reduce units of platelets; and two products aimed at red blood cells, S-303 (a Frale--frangible anchor-linker effector compound) and Inactine (a binary ethyleneimine). A final pathogen-reduction material that might actually allow one material to inactivate all three blood components--riboflavin (vitamin B2)--is also under development. The sites of action of the amotosalen (S-59), the S-303 Frale, Inactine, and riboflavin are all localized in the nucleic acid part of the pathogen. Solvent detergent materials act by dissolving the plasma envelope, thus compromising the integrity of the pathogen membrane and rendering it non-infectious. By disrupting the pathogen's ability to replicate or survive, its infectivity is removed. The degree to which bacteria and viruses are affected by a particular pathogen-reducing technology relates to its Gram-positive or Gram-negative status, to the sporulation characteristics for bacteria, and the presence of lipid or protein envelopes for viruses. Concerns related to photoproducts and other breakdown products of these technologies remain, and the toxicology of pathogen-reduction treatments is a major ongoing area of investigation. Clearly, regulatory agencies have a major role to play in the evaluation of these new technologies. This chapter will cover the several types of pathogen-reduction systems, mechanisms of action, the inactivation efficacy for specific types of pathogens, toxicology of the various systems and the published research and clinical trial data supporting their potential usefulness. Due to the nature of the field, pathogen reduction is a work in progress and this review should be considered as a snapshot in time rather than a clear picture of what the future will bring.

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Universal fresh frozen plasma (Uniplas): a safe product in open-heart surgery

Abstract: In open-heart surgery, Uniplas, which can be transfused regardless of a patient's blood group, was well-tolerated and gave no adverse drug reactions.

Cited by 29 publications

References 20 publications

The Use of Solvent/Detergent Treatment in Pathogen Reduction of Plasma

The Use of Solvent/Detergent Treatment in Pathogen Reduction of Plasma

Solvent/detergent plasma: pharmaceutical characteristics and clinical experience

Pathogen inactivation techniques

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