An active hemovigilance program characterizing the safety profile of 7483 transfusions with plasma components prepared with amotosalen and UVA photochemical treatment

Cazenave, Jean‐Pierre; Waller, C.; Kientz, Daniel; Mendel, Isabelle; Lin, Lily; Jacquet, Michèle; Propst, Meisa; Liu, Weiqun; Corash, Laurence; Sundin, David J.; Defoin, Laurence; Messe, N.; Osselaer, Jean-Claude

doi:10.1111/j.1537-2995.2009.02579.x

Cited by 44 publications

(57 citation statements)

References 24 publications

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“…Amotosalen/UVA‐treated PCs have demonstrated efficacy for treatment and prevention of bleeding in large randomized controlled clinical trials . Efficacy and safety were confirmed under routine‐use conditions, as reported to large national haemovigilance programmes and in industry‐sponsored postmarketing comparative effectiveness studies .…”

Section: Introductionmentioning

confidence: 75%

Patient outcomes and amotosalen/UVA‐treated platelet utilization in massively transfused patients

et al. 2017

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Background Amotosalen/UVA-treated platelet concentrates (PCs) have demonstrated efficacy for treating and preventing bleeding in clinical trials and in routine use; however, most studies were performed in haematology/oncology patients. We investigated efficacy during massive transfusion (MT) in general hospitalized patients.Methods Universal amotosalen/UVA treatment (INTERCEPT Blood System) of platelets was introduced at a large Austrian medical centre. We performed a retrospective cohort analysis comparing component use, in-hospital mortality and length of stay after MT that included platelet transfusion, for two periods (21 months each) before and after implementation.Results A total of 306 patients had MT. Patients were mostly male (74%) and ≥18 years old (99%), including 93 liver transplant, 97 cardiac or vascular surgery and 51 trauma patients. There were no differences in demographics between the periods. Component use on the day and within 7 days of the MT event was unchanged post-IBS implementation, except trauma patients received fewer RBCs on the day. The mean ratio of RBC:platelets:plasma on the day of the MT was close to 1:1:1 in both periods, except for liver transplants with MT who received more plasma components. Overall, in-hospital mortality (preimplementation = 27Á6% vs. postimplementation = 24Á0%; P = 0Á51) and median time to discharge (preimplementation = 27 vs. postimplementation = 23 days; P = 0Á37) did not change, except for cardiac and vascular surgery patients who were discharged earlier. ConclusionThe introduction of amotosalen/UVA-treated, pathogen-reduced PC did not adversely affect clinical outcomes in massively transfused patients in terms of blood product usage, in-hospital mortality and length of stay for a range of clinical indications for platelet transfusion support.

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Section: Introductionmentioning

confidence: 75%

Patient outcomes and amotosalen/UVA‐treated platelet utilization in massively transfused patients

et al. 2017

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“…The INTERCEPT Blood System using amotosalen and UVA light to treat PLT and plasma components for the purpose of pathogen inactivation has been developed and introduced into routine clinical practice 10‐13 . There are two essential elements in the development of a pathogen inactivation method for blood components.…”

Section: Discussionmentioning

confidence: 99%

The extent of amotosalen photodegradation during photochemical treatment of platelet components correlates with the level of pathogen inactivation

et al. 2011

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“…No antibodies were demonstrated to the amotosalen compound and no accumulation of drug was noted over time. The clinical experience with INTERCEPT plasma has been described in hemovigilance reports from Belgium and France, attesting to its equivalence to FFP in general clinical use 35,36 …”

Section: Pathogen‐reduced Plasma Products In Widespread Use Outside Omentioning

confidence: 97%

Plasma components: properties, differences, and uses

2012

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General use of plasma components includes replacement for multiple coagulation factor deficiencies, for treatment of single coagulation factor deficiencies for which a concentrate is unavailable, and as a replacement fluid used in therapeutic plasma exchange for thrombotic thrombocytopenic purpura. Four major products currently transfused are fresh‐frozen plasma (FFP), plasma frozen within 24 hours of phlebotomy (FP24), cryoprecipitate‐poor plasma (CPP), and thawed plasma. FP24, CPP, and thawed plasma contain decreased amounts of labile coagulation factors. Pathogen reduction technology has included solvent/detergent, methylene blue, and ultraviolet light irradiation with psoralen or riboflavin treatment and is available in Europe but not in the United States. Pathogen‐reduced plasma may contain reduced levels of certain coagulant and/or anticoagulant factors compared to FFP. Clinical findings with pathogen‐reduced plasma have provided an impetus to the US Food and Drug Administration to promulgate specific requirements for approval of novel plasma products, some of which may be too burdensome for the industry to readily overcome.

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An active hemovigilance program characterizing the safety profile of 7483 transfusions with plasma components prepared with amotosalen and UVA photochemical treatment

Abstract: PCT-plasma transfusions were well tolerated in routine clinical use. The EDCS HV program facilitated collection and reporting of safety information on a real-time basis from multiple sites.

Cited by 44 publications

References 24 publications

Patient outcomes and amotosalen/UVA‐treated platelet utilization in massively transfused patients

Patient outcomes and amotosalen/UVA‐treated platelet utilization in massively transfused patients

The extent of amotosalen photodegradation during photochemical treatment of platelet components correlates with the level of pathogen inactivation

Plasma components: properties, differences, and uses

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