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.

Adverse transfusion reactions in recipients transfused in out-of-hospital.

OBJECTIVES: Transfusion in environments other than inpatient hospitalisation requires a specific management of the patient, particularly concerning adverse transfusion reactions. A three-year study was carried out in order to appreciate the nature of adverse transfusion reactions and their incidence in these patients. MATERIAL AND METHODS: Adverse transfusion reaction reports of outpatient clinic, ambulatory hospital, health and dialysis centres and home-transfused patients in the Auvergne Rhône Alpes region were obtained. Diagnosis of adverse transfusion reactions, their incidence, their degree of severity, the imputability of the blood component concerned were evaluated. RESULTS: From 1 January 2014 to 31 December 2016, 3,284 reports were notified. Excluding allo-immunisations, 416 reports were obtained, including 376 (90.4%) in outpatient clinic. The febrile non-haemolytic transfusion reaction was the most frequent adverse transfusion reaction (119 cases, 28.6%) followed by allergy (112 cases, 26.9%). A transfusion-associated circulatory overload was notified in 26 cases (6.3%). Among the 416 reports, 363 were non-severe and in 251, a red blood cell concentrate was involved (60.3%). The imputability of the blood product was certain in 50 cases (12.0%) only. CONCLUSION: With the exception of inpatient hospitalisation and allo-immunisation, the majority of adverse transfusion reactions was notified in outpatient clinic. The febrile non-haemolytic transfusion reaction was the most frequent.

The epidemiology and virology of hepatitis C virus genotype 5 in central France.

BACKGROUND: We previously reported high prevalence of hepatitis C virus genotype 5a (HCV 5) (14%) in Central France. AIM: To identify the risk factors associated with HCV5 infection and to characterize local HCV5 lineages. METHOD: A case-control study and phylogenetic analysis were conducted. RESULTS: In all, 131 HCV5 and 343 HCV non 5 infected patients were enrolled. No HCV5 patient was born in sub-Saharan Africa and only two were injection drug user. HCV5 contamination was associated with living in a rural area called Vic le Comte (VLC) in non-transfused patients (OR = 17.7), with transfusion in patients living outside VLC (OR = 3.8) and with receiving injections in patients from VLC (OR = 3.1). More than 80% of the patients from outside VLC were contaminated by transfusion and those from VLC mainly by an iatrogenic factor - injections performed before 1972 by the local physician. Phylogenetic analysis of HCV5 isolates evidenced no distinct genetic cluster, but close relationships between the isolates of spouse pairs and between blood donors and recipients. CONCLUSIONS: Our results suggest that HCV5 spread in our district by iatrogenic route before 1972 and then via transfusion to the whole district. Collaborative studies are underway to study viral sequences from different parts of Africa and Europe to estimate the origin of our HCV 5a strains.

[Evaluation of continuous education in transfusion for professionals in hospitals and clinics]. / Evaluation d'un enseignement en transfusion sanguine proposé aux professionnels des établissements de santé.

Professional health workers need continuous update of knowledge in blood transfusion practice. To fulfill this expectation, the "Etablissement français du sang (E.F.S) Auvergne-Loire", in cooperation with the Department of Regional Affairs in Health Services in the Auvergne region, has set up a proximity-based and a dedicated continuous education course, for more than three years. The content of this update course was based upon regulatory recommendations. The course is one day long; an evaluation of the course by the teachers as well as an evaluation of the teachers' level after the course is carried out. Each course attendant is given a CD-ROM which comprises all of the presentations of the day, along with relevant law texts. We now report on our experience in teaching 127 individual professionals in eight sessions: 95% gave full appreciation. This experience reached - up to now - 53% of the public and private hospitals with transfusion services in the Auvergne region and the Loire district and 90% of structures having remote blood banks. This experience can easily be extended to other regional E.F.S. settings.

[Analysis of a severe septic transfusion reaction with standard platelet concentrate]. / Analyse d'un incident bactérien grave transmis par transfusion d'un concentré plaquettaire.

We recently observed a near fatal case of transfusion-transmitted infection with standard platelet concentrate. Streptococcus dysgalactiae subspecies equisimilis was isolated both from donor, residual component container and cultures of the patient's blood. This should question the usefulness of systematic bacterial detection in platelet concentrates, however a lethal accident has occurred recently which escaped bacterial detection. This observation calls for implementation of pathogen inactivation procedures for platelets concentrates.