Recovery, safety, and tolerability of a solvent/detergent‐treated and prion‐safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers

Jilma‐Stohlawetz, Petra; Kursten, Friedrich W.; Horvath, Michaela; Leitner, Gerda; List, Jana; Marcek, Jana; Quehenberger, Peter; Schwameis, Michael; Bartko, Johann; Derhaschnig, Ulla; Jilma, Bernd

doi:10.1111/trf.12075

Cited by 17 publications

(21 citation statements)

References 18 publications

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“…Octaplas is now available with a dedicated prion reduction step by affinity chromatography (OctaplasLG, Octapharma AG) which has been shown to have similar profiles of ADAMTS13 activity and ULVWF to regular SDP 20. OctaplasLG has been used in healthy volunteers and appears to be equivalent to Octaplas in regard to clotting factor recovery and safety 21. Given its potential enhanced safety, prion-reduced SDP plasma may therefore become the product of choice in the future after its safety and efficacy has been further validated.…”

Section: Management Of Ttpmentioning

confidence: 99%

Management of thrombotic thrombocytopenic purpura: current perspectives

Blombery¹,

Scully²

2014

JBM

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Thrombotic thrombocytopenic purpura (TTP) is a rare, life-threatening thrombotic microangiopathy which causes significant morbidity and mortality unless promptly recognized and treated. The underlying pathogenesis of TTP is a severe deficiency in ADAMTS13 activity, a metalloprotease that cleaves ultralarge von Willebrand factor multimers. This deficiency is either autoantibody mediated (acquired TTP) or due to deleterious mutations in the gene encoding ADAMTS13 (congenital TTP). The elucidation of this disease mechanism has reinforced the rationale and place of current therapies (eg, plasma exchange) as well as providing a basis for the prospective evaluation of immunotherapy with rituximab in addition to classic immunosuppression (eg, corticosteroid) in autoantibody-mediated TTP. This review discusses the current evidence base for therapeutic interventions in acquired and congenital TTP as well as providing a practical approach to the other aspects of investigation and management for which a firm evidence base is lacking. Novel agents that are currently being evaluated in prospective trials and future directions of therapy are also discussed which are expected to make an important contribution to improving outcomes in patients with TTP.

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Section: Management Of Ttpmentioning

confidence: 99%

Management of thrombotic thrombocytopenic purpura: current perspectives

Blombery¹,

Scully²

2014

JBM

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“…OctaplasLG is used in different countries routinely since several years and a recently performed clinical trial showed that Octaplas as well as OctaplasLG compensate well for the loss of clotting factors after apheresis [17].…”

Section: Discussionmentioning

confidence: 99%

The state of the art of removal of prion proteins in SD-FFP, by specific prion affinity chromatography and its impact on the hemostatic characteristics of the product

Neisser-Svae

Seghatchian

2015

Transfusion and Apheresis Science

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In recent Coimbra' Conference, on the pre-launch of pathogen reduced-FFP for the local clinical use, the question was raised, by the moderator, on the efficacy of the current methodology used for prion removal processes and its influence on the overall quality and safety of the final product. This brief paper put together by speaker of this session and the moderator, as a consensus of opinions, which was largely discussed during Q&A session, to make it available to a large group of readers of transfusion apheresis science, who might be interested to this topic. In short the capacity of the current process of Octaplas to remove prion is in order of 5.6 log10/ID50 reduction based on several animal studies. Moreover the changes in coagulation and inhibitors are within acceptable range and bioequivalent to untreated FFP with no sign of inferiority. This paper describes in brief a technology update on solvent/detergent treated plasma, an alternative to FFP but with increased pathogen safety. The biochemical profile of the final product is comparable with FFP and contains all clinically relevant plasma proteins. Furthermore, Octaplas is a product that, in long term, reduces health care costs.

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“…However, the resulting product is totally bioequivalent to S/D plasma and shows comparable recovery of clotting factors and comparable safety and tolerability [13]. The change in the manufacturing process, where the S/D treatment is consistently reduced, produces increased plasmin inhibitor concentrations in the plasma product and significantly higher plasma concentrations of plasmin inhibitor after transfusion in vivo [14].…”

Section: The Methods Of Inactivationmentioning

confidence: 99%

Solvent/detergent-treated plasma: a tale of 30 years of experience

Liumbruno

Marano

Grazzini

et al. 2015

Expert Review of Hematology

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Solvent/detergent-treated plasma was licensed >30 years ago. It has several specific characteristics, the most important being the standardized content of clotting factors, the lack of antibodies implicated in transfusion-related acute lung injury pathogenesis and the very high level of safety against transfusion-related viral infections. Since 1992, many clinical studies have confirmed its safety and efficacy in a wide range of congenital and acquired bleeding disorders. After a brief analysis of the pharmaceutical characteristics of solvent/detergent plasma, this review will focus on the clinical experience with this virus-inactivated plasma.

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Recovery, safety, and tolerability of a solvent/detergent‐treated and prion‐safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers

Abstract: The LG plasma product was bioequivalent to its predecessor with respect to recovery of clotting factors and demonstrated comparable safety and tolerability in healthy volunteers. Both products compensated well for the loss of clotting factors after apheresis (NCT01063595).

Cited by 17 publications

References 18 publications

Management of thrombotic thrombocytopenic purpura: current perspectives

Management of thrombotic thrombocytopenic purpura: current perspectives

The state of the art of removal of prion proteins in SD-FFP, by specific prion affinity chromatography and its impact on the hemostatic characteristics of the product

Solvent/detergent-treated plasma: a tale of 30 years of experience

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