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).

[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.

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.

[Pediatric transfusion practices: A single-center retrospective study]. / Pratiques transfusionnelles en pédiatrie : étude rétrospective monocentrique.

OBJECTIVES: This study aimed to describe the professional practices in pediatric transfusion to assess the accuracy of transfusion guidelines in children. METHODS: The study retrospectively analyzed the characteristics of all the pediatric transfusions prescribed in the Clermont-Ferrand (France) university hospital center over 1 year and determined whether they conformed to the national guidelines. RESULTS: One thousand six hundred and seven blood products were delivered to 233 children (806 red cell units, 670 platelet units, and 131 plasma units), accounting for 5.3% of the center's whole blood products. Transfusions were mainly prescribed by the oncohematology unit (68.2%), the intensive care unit (15.4%), and for surgery (10.2%). Ten adverse events were reported in eight patients (0.6% of transfusions). The prescription conformed to the national guidelines in 35.9%, 41.6%, and 80.9% of the red blood cell, platelet, and plasma unit transfusions, respectively. Nonconformity was mainly due to abusive irradiation and "cytomegalovirus seronegative" specifications. CONCLUSION: Malignancies, intensive care, and surgery are the main indications for transfusion in children. Substantial discrepancy between recommendations and actual practices was observed. This illustrates the variability of risk evaluation. This should be made simpler by the use of photochemical pathogen inactivation techniques.

[Pathogen inactivation of platelets: organization consequences for platelet transfusion]. / Inactivation/réduction des pathogènes des concentrés de plaquettes: conséquences sur l'organisation de la transfusion plaquettaire.

In the past few years, pathogen reduction technologies for labile blood products have been part of the enhancement of global transfusion safety regarding residual risks of transmitting infectious pathogens. Having carried out a feasibility study for the implementation of pathogen inactivation of platelet concentrates by means of the amotosalen/HCl/UVA (Intercept™) technology, and participated to a reinforced haemovigilance study, we took the opportunity to analyze the organization consequences for platelet concentrates inventory and distribution. This impact study first indicated that those novel needs forced the blood donation service, as well as the labile blood product preparation laboratory, to review and improve practices; secondly, it showed that the routine implementation has little (no major) consequence in the overall organization, independently of the economic consequences (not covered here).

[Evaluation of continuous education in transfusion for professionals in medical blood banks]. / Évaluation d'une formation en transfusion sanguine à destination des personnels des dépôts de sang.

PURPOSE OF THE STUDY: Like every actor in transfusion, staff members practising within blood banks of healthcare establishments have to follow a specific initial training and must frequently update their knowledge in blood transfusion. METHODS: To address this need from these professionals, the Établissement français du sang Auvergne-Loire set up training sessions which content regularly evolved according to regulation recommendations. Every cycle consists in a total of 35hours of training, divided in five one-day modules. The comparison of the evaluation questionnaires offered at the beginning and at the end of each day allowed to measure the benefits provided by every module and to compare progress according to the number of modules previously followed. The analysis of satisfaction surveys contributed to improving the education towards a high level of satisfaction of every participant. RESULTS CONCLUSION: At the end of its third year of existence, the 35hours education programme permitted to achieve a better level of training for all the staffs and the evolution towards an on-site continuing education format seems to better correspond to the personnel's expectations.

[Post-transfusion pulmonary oedema: the French hemovigilance network classification method]. / Œdèmes pulmonaires transfusionnels: classification des cas notifiés en hémovigilance.

Pulmonary oedema after transfusion of blood products may be hydrostatic (transfusion-associated circulatory overload [taco]) or exsudative (transfusion-related acute lung injury [trali]). Both conditions have been recognized as major hazards to transfusion recipients. Risk characterization is necessary to improve safety and to monitor trends in the national blood transfusion system. A collaborative multidisciplinary working group of the French National Hemovigilance Committee has proposed an analysis framework for case definitions and classification. The method relies on internationally used definitions and is adapted to the codification procedures used in the french transfusion incident reports electronic data management.

[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.

[Tranfusion counseling]. / Le conseil transfusionnel.

In this article, we present transfusion counseling; its organization, actors, their formations and we deal with factual positions. Transfusion counseling needs better identification, tending to a homogeneous organization between every bloodbank centre.

[Experience with the regionalization of transfusion advice]. / Expérience de régionalisation du conseil transfusionnel.

We represent an organization of transfusionnel advice at a regional level and we develop arguments and stages having allowed us to lead to this choice. This target was reached in two stages, which took place over 3 years. The regional transfusionnel advice leans on three fundamental points: a planned permanent organization, skilled and formed actors as well as adapted tools. Tending to a homogeneous organization between every blood bank center seems to be coherent towards the current configuration of blood donation in France.

An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment.

BACKGROUND: An active haemovigilance programme was implemented to survey adverse events (AE) associated with transfusion of platelets photochemically treated with amotosalen and ultraviolet A (PCT-PLT). The results of 5106 transfusions have already been reported. Here we report the results of an additional 7437 PCT-PLT transfusions. METHODS: The focus of this ongoing haemovigilance programme is to document all AEs associated with PCT-PLT transfusion. Data collected for AEs include: time of event after starting transfusion, clinical descriptions, vital signs, results from radiographs and bacterial cultures, event severity (Grade 0-4) and causal relationship to PCT-PLT transfusion. RESULTS: One thousand four hundred patients (mean 60 years, range 1-96) received PCT-PLT transfusions. The majority of the patients (53.4%) had haematology-oncology diseases and required conventional chemotherapy (44.8%) or stem cell transplantation (8.6%). Sixty-eight PCT-PLT transfusions were associated with AE. Acute transfusion reactions (ATR), classified as an AE possibly related, probably related, or related to PCT-PLT transfusions were infrequent (n = 55, 55/7437 = 0.7%) and most were of Grade 1 severity. Thirty-nine patients (39/1400 = 2.8%) experienced one or more ATRs. The most frequently reported signs/symptoms were chills, fever, urticaria, dyspnoea, nausea and vomiting. Five AEs were considered severe (> or = Grade 2); however, no causal relationship to PCT-PLT transfusion was found. Repeated exposure to PCT-PLT did not increase the likelihood of an ATR. No cases of transfusion-related acute lung injury and no deaths due to PCT-PLT transfusions were reported. CONCLUSIONS: Routine transfusion of PCT-PLT is well-tolerated in a wide range of patients. ATRs related to PCT-PLT transfusion were infrequent and most were of mild severity.

[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.