Adverse transfusion reactions with neurological signs in transfused patients.

OBJECTIVES: Many transfused patients present severe, sometimes critical, clinical conditions. The occurrence of adverse transfusion reactions may cause the clinical condition to deteriorate. A study was conducted aimed at establishing whether the presence of neurological signs during an adverse transfusion reaction increases its severity. METHODS: From 1 January 2010 to 30 June 2019, adverse reactions with neurological signs were extracted from the French haemovigilance database system. Two signs observed at the time of the reaction were analysed: unconsciousness and convulsions. Stroke was excluded. The type of reaction, its severity, the blood product involved and its imputability were all studied. RESULTS: During the study period, 10,670 reactions were reported, including 20 (0.19%) imputed to the transfusion with unconsciousness and/or convulsions. Unconsciousness without convulsions was frequently observed (14 reports, 70.0%). Convulsions were reported in 5 cases (25.0%), with 1 case being associated with unconsciousness. Unconsciousness and/or convulsions were present in 9 allergic reactions (45.0%) and 4 transfusion-associated circulatory overloads (20.0%). Nine reactions were severe (45.0%), 7 were life-threatening (35.0%) and 1 case resulted in the recipient's death (5.0%). A red blood cell and a platelet concentrate transfusion were involved in 8 reactions (40.0%) each, although the imputability of the blood product was certain in only 2 of the reactions. CONCLUSION: Unconsciousness and/or convulsions were rarely observed in adverse reactions reported in transfused patients. Nevertheless, the presence of these signs highlights the severity of the adverse reactions (17 reactions, 85.0%).

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.

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.

[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.

[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.