Independent evaluation of tolerance of therapeutic plasma inactivated by amotosalen-HCl-UVA (Intercept ™) over a 5-year period of extensive delivery.

Amotosalen-HCl-UVA (AI) is a process to inactivate pathogens in therapeutic plasma (FFP). Tolerance is the main residual issue in FFP transfusion, and only large series observations are powered enough to identify significantly elevated levels of hazards. We report here on 15,133 new transfusions of AI-FFP, over the previously published 36,035, which in all represents one of the largest series observed by means of a highly standardized surveillance (51.168 observations). There is no noticeable difference in terms of tolerance of AI-FFP compared to 5875 transfusions of Quarantine (Q)-FFP. There was no significant difference in terms of advance events, between the two types of FFP (P = 0.98); further, no difference was recorded either when the total number of AI-FFP (51,168) was compared to the corresponding number of Q-FFP (5875; P = 0.62).

A regional haemovigilance retrospective study of four types of therapeutic plasma in a ten-year survey period in France.

BACKGROUND AND OBJECTIVES: Our objective was to compare the frequency of adverse events (AEs) due to any of the 4 types of fresh-frozen plasma (FFP) prepared and delivered by the French Blood Establishment (EFS) over a 10-year period. Surveillance of AEs and vigilance was performed according to a homogeneous policy. The four types of FFP comprised of one type (methylene blue [MB) that was stopped since then and of another type [amotosalen (AI)] that was recently introduced, along with two conventional products [quarantine (Q) and solvent-detergent (SD)]. MATERIALS AND METHODS: This is a retrospective study based on the national AE reporting database and on the regional database system for deliveries. AEs recorded after the delivery of 1 of the 4 types of FFP were pairwise compared, with appropriate statistical corrections. RESULTS: 105,964 FFP units were delivered (38.4% Q, 17.9% SD, 9.7% MB and 34% AI). Statistical comparisons of AEs identified only a difference in AE rates between quarantine and solvent-detergent plasma. CONCLUSIONS: FFP was confirmed to be extremely safe in general, especially if one considers 'severe' AEs. All types of FFP were associated with extremely low occurrences of AEs. Q, SD, MB and AI led, respectively, to 7.14, 4.86, 1.05 and 4.16 AEs per 10,000 deliveries.

[The different types of therapeutic plasma are equivalent?]. / Les différents types de plasmas thérapeutiques sont-ils équivalents ?

In France, three varieties of therapeutic plasma are being processed, distributed and delivered, currently; however, many more varieties are in use worldwide, which go by the property of labile blood component or plasma derived medicines. For one type of component (one given name), several devices and bags and so on are used to concur to its process, which makes that one type of therapeutic plasma may significantly differ from one production setting to one other. This may affect (more or less) the component properties as well as the possibly reported adverse events. This review aims thus, firstly at stressing on the difficulty in comparing data obtained in different contexts, and secondly at making the point on future directions to process therapeutic plasma.