[Comparative study on platelet transfusion in Lorraine-Champagne and Alsace in 2015]. / Étude comparative des transfusions de concentrés plaquettaires en Alsace et en Lorraine-Champagne en 2015.

OBJECTIVES: To find explanations for the observed differences of platelets concentrates (PC) deliveries between 2 French regions, Lorraine-Champagne (LOCH) and Alsace (ALSA). METHODS: This is a non-interventional prospective study, performed during 30 days in 2015 in intensive care, cardiovascular surgery and onco-hematological wards of 8 LOCH and ALSA hospitals. Questionnaires listing clinical and biological parameters were attached to the prescription forms and filled in at each PC prescription. RESULTS: In all, 290 patients, 1093 prescriptions and 1093 deliveries of PC were analyzed. The pre-transfusional context (patient weight, prophylactic or curative situation, pre-transfusional platelet count) were homogenous. The phasing of the prescription forms wording had a direct impact on the doses' formulation : 100 % of the LOCH forms were expressed in platelet quantity (PQ), vs 22 % in ALSA. The mean interval between 2 transfusions was 2.9 days in ALSA vs 4.9 days in LOCH. The mean PQ/delivery was higher in ALSA (5.6.1011 vs 4.0.1011 in LOCH). The delivered PQs were compared to the 2003 French recommendations that were in force in 2015. Twenty-seven percent of the LOCH delivered PQs were in the recommended interval, vs Forty-nine percent in ALSA. Due to the systematic delivery of a single PC unit, including weights>80Kg, LOCH presented 63 % insufficient PQ deliveries. Twenty-two percent of the deliveries in ALSA were over the recommended interval, mostly linked with the simultaneous delivery of a second PC. CONCLUSION: This study identifies disparities in terms of prescription and delivery between LOCH and ALSA, which may explain their respective PC consumption levels.

The International Haemovigilance Network Database for the Surveillance of Adverse Reactions and Events in Donors and Recipients of Blood Components: technical issues and results.

BACKGROUND AND OBJECTIVES: The International Haemovigilance Network's ISTARE is an online database for surveillance of all adverse reactions (ARs) and adverse events (AEs) associated with donation of blood and transfusion of blood components, irrespective of severity or the harm caused. ISTARE aims to unify the collection and sharing of information with a view to harmonizing best practices for haemovigilance systems around the world. MATERIALS AND METHODS: Adverse reactionss and adverse events are recorded by blood component, type of reaction, severity and imputability to transfusion, using internationally agreed standard definitions. RESULTS: From 2006 to 2012, 125 national sets of annual aggregated data were received from 25 countries, covering 132.8 million blood components issued. The incidence of all ARs was 77.5 per 100 000 components issued, of which 25% were severe (19.1 per 100 000). Of 349 deaths (0.26 per 100 000), 58% were due to the three ARs related to the respiratory system: transfusion-associated circulatory overload (TACO, 27%), transfusion-associated acute lung injury (TRALI, 19%) and transfusion-associated dyspnoea (TAD, 12%). Cumulatively, 594 477 donor complications were reported (rate 660 per 100 000), of which 2.9% were severe. CONCLUSIONS: ISTARE is a well-established surveillance tool offering important contributions to international efforts to maximize transfusion safety.

[Physicians' perception on taking care of Jehovah's witnesses]. / Perception par les médecins des conditions de prise en charge d'un Témoin de Jéhovah.

PURPOSE OF THE STUDY: The goal of this study is to assess the physician's management of patients who refuse blood transfusion. MATERIAL AND METHODS: A questionnaire to assess the experience, the acceptance or refusal and the operating methods in case of vital risk has been realized and circulated at a national scale. RESULTS: A total of 793 questionnaires were sent back and analysed according to 3 different categories: anesthesiologists, physicians and surgeons. Seventy-nine percent of total respondents and 90% of anesthesiologists had had to take care of a Jehovah's Witness. In 51% of all cases, it appears to be associated with mainly relational problems with the patient or his family. Nevertheless, 83% accept to take care a Jehovah witness, the most reluctant of them being anesthesiologists. A written confirmation of blood transfusion refusal even at vital risk and a piece of written evidence of belonging to Jehovah's Witnesses are not systematically required. For them, the impossibility to foresee with certainty the need for blood transfusion represents the main barrier to the medical care of a Jehovah's Witness. In case of imminent vital risk and if there are no available alternative procedures, 67% of respondents administer blood products (89% if the patient is unconscious). CONCLUSION: This situation has nothing exceptional but the medical community does not seem to know all the regulatory requirements. Generally speaking, they do not oppose the medical care of a Jehovah's Witness, but remain committed to their primary focus: to save the patient, as long as it is not an end-of-life situation.

[Sickle cell pathophysiology]. / Physiopathologie de la drépanocytose.

Sickle cell disease is associated with the inversion of one base pair (A = T → A = T). The sixth codon of the beta globin chain [GAA] becomes [GTA]. Accordingly, the sixth amino acid (glutamic acid, negatively charged) is replaced by valine, hydrophobic. A hydrophobic site is present on the outside of the HbS ß chain. This incurs a hydrophobic bond with the phenylalanine in position 85 and leucine in position 88, in which outsource deoxy haemoglobin. Therefore, it creates a HbS polymer that deforms the red blood cell and causes vaso-occlusive crisis in the capillary venous pole. In this conventional design, the roles are added to the nitrogen monoxide and vascular tone, the increase in adhesion of red blood cells to the endothelium damage caused by red blood cells HbS: dehydration, senescence, formation of microvesicles. If these advances in our understanding of the pathophysiology have not yet had a clinical application, they will happen one day. It is therefore particularly important to pursue in France the network structure of sickle cell disease with a view to set up multicenter trials when the day comes.

[Evaluation of transfusion hemochromatosis prevalence, SFVTT-01 study: preliminary results of the SFVTT working group]. / Évaluation de la prévalence de l'hémosidérose post-transfusionnelle, étude SFVTT-01: résultats préliminaires du groupe de travail de la SFVTT.

RATIONAL: Although notification of post-transfusion hemosiderosis is mandatory since 1994 among the French hemovigilance network, it is so far largely under reported. PATIENTS AND METHODS: We screened 42,443 patients hospitalized for blood diseases in France in 2009 and 2010 and determined which patients had received more than 20 PRC. Among them, we selected those having at least one measure of serum ferritin, and subsequently those which ferritin was greater than or equal to 1000 ng/mL. RESULTS: Three thousand eight hundred and twelve patients (9%) received more than 20 PRC, 1935 (4.5%) had a ferritin assay, which was increased in 1216 patients (2.9%). Eight hundred and eighty-one patients underwent an hemovigilance report form. Forty-nine percent had low-risk myelodysplasia or acute leukemia, 7% hemoglobinopathies. Hemosiderosis was asymptomatic for 680 patients (77%), serious 188 (88%) and life-threatening for 11 (1%). Two patients died of terminal heart failure. The most severe hemosiderosis (≥ grade 2) were low-risk myelodysplasia and idiopathic aplastic anemia. Ninety-two percent of thalassemia patients and 46% of sickle cell anemia patients received an iron chelator. For low-risk myelodysplastic syndromes and idiopathic aplastic anemia, 228 of the 317 patients whose treatment is known and who could benefit from iron chelation (72%) have not received it. CONCLUSION: These results encourage seeking optimal transmission of information (over 20 CGR) to the clinician, and prolonging hemovigilance action towards a more comprehensive statement of post-transfusion hemochromatosis.

[Computerization of hospital blood banks in France: what has been done and what remains to be done]. / Informatisation des dépôts de sang: ce qui est fait et ce qui reste à faire.

French regulation requires hospital blood banks to have data processing of their blood transfusion activities. In order to help them to achieve this goal, guidelines were published by an official working party. For their diffusion, a study was launched to assess current gaps between guidelines and reality. Analysis of the first forty responses shows: 1) computerization is already set up for main blood banks and is going well for the others; 2) most of guideline functionalities are now working in main blood banks; but some points need specific developments; 3) taken as a whole, other blood banks are further from guideline requirements, even if some have already reached the goal; 4) guidelines are able to point out to all hospital blood banks what remains to be done.

[Specific hazards of transfusion in medical units]. / Risques spécifiques de la transfusion en médecine.

In France, more than 1100 hospitals have medical wards with specialty units that perform transfusions and use about 40% of all labile blood products. Due to patients suffering from multiple pathologies, repeated transfusions or use of platelet concentrates, these hospital units encounter specific and more frequent transfusion hazards than other wards. The incidence rate of transfusion associated cardiac overload, anti-erythrocyte, -HLA or -HPA allo-immunisations or transfusion-induced hemochromatosis, is high. Platelet concentrates may also cause severe allergic reactions. They are still under-reported, though immediate or delayed effects on patients or care processes are considerable. The prevention of these adverse reactions or of their consequences requires careful prescription, properly planned and organised patient stays, particularly at the day hospital, with special attention to coordination of doctors and nurses. Labelling errors of blood group samples or blood administration to the wrong patient are the most frequent serious adverse events. Main underlying causes are: a poor understanding of specific hazards of transfusion in medical wards, routine, multiple transfusions and permanent or occasional working overload. So, both doctors and nurses should do their best to improve organisation and systematically comply with good clinical practice.

[Factsheets: support in the analysis of recipients' adverse reactions]. / Fiches techniques: aide à l'analyse des effets indésirables receveurs.

In order to help the analysis of adverse effects of transfusion, factsheets have been written by working groups of the French agency for the safety of health products ANSM. Each factsheet deals with a blood transfusion side effect and is composed of five parts, including pathophysiological mechanisms, diagnostic criteria, management recommendations, etiologic investigations and rules for filing the notification form to ANSM. Since 2006, 11 factsheets have been published on the French haemovigilance network website. The major characteristics of the two last sheets published "post-transfusion purpura" and "non erythrocyte incompatibility reaction" are presented, followed by the updated card for "allergy". These factsheets give relevant guidelines allowing better evaluation of recipients' adverse reactions, particularly their diagnosis, severity and accountability. They also could initiate studies among European and international haemovigilance networks.

[Seventeen years of haemovigilance in France: assessment and outlook]. / Dix-sept ans d'hémovigilance en France: bilan, perspectives.

Since 1994, the French haemovigilance network has not stopped evolving. Based initially on the reporting of informations and incidents related to recipients, it quickly became interested in the procedures and other activities related to blood component transfusion, in order to improve blood safety. Despite some failures (under reporting, heavy declarative management), the French haemovigilance network is going to continue working on improving blood safety, both at the level of the recipients and the donors, and participate to the global improvement of quality of care.

[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.

[Heart failure and stasis ulcer: A significant association (prospective study of 100 cases)]. / Insuffisance cardiaque et ulcère de stase : une association significative (étude prospective de 100 cas).

BACKGROUND: Risk factors for stasis ulcers have been poorly studied. We conducted a three-year controlled prospective study of the usual risk factors [venous insufficiency (VI), obesity, phlebitis] and of other factors suggested by our experience, such as heart failure (HF). PATIENTS AND METHODS: Both in-patients and out-patients referred for stasis ulcers were included. The diagnosis of stasis ulcer was based on clinical criteria: venous insufficiency, cutaneous signs and/or severe leg oedema. Doppler ultrasound was performed systematically if the lesions showed no dramatic improvement within two months of treatment to eliminate arterial ulcers. VI, liver cirrhosis, heart failure, deep venous thrombosis, obesity, after-effects of leg injury, homolateral artificial hip and knee joints, and consumption of anti-leukaemia or leg-oedema-eliciting drugs were the criteria analysed by clinical examination or by consulting the information in the hospital records. Data were analyzed using SPSS/PCv12 software. Chi(2) and Fischer's exact tests were to compare cases and controls, who were identical in age, gender, and department of initial contact for reasons other than leg ulcers, stasis eczema or lipodermatosclerosis. RESULTS: We included 100 cases and 200 control subjects. Most were out-patients and only 4% were hospitalized in cardiology. Univariate analysis showed that stasis ulcer was significantly associated (p < 10(-4)) with VI (71% of cases versus 32.5% of control subjects), HF (44% versus 11%), obesity (44% versus 21.5%), after-effects of injury (17% versus 0%), and to a lesser extent, with artificial knee joints (7% versus 2.5%; p = 0.04). Multivariate analysis showed that stasis ulcer was strongly associated with VI (OR=5.5; 3-9.9) and HF (OR=4.7; 2.1-10.4). HF (right 16%, left 11%, global 57%, unspecified 16%) was also significantly associated with bilateral localization of leg ulcers (p = 10(-4)) but not with delayed healing (> 6 months). DISCUSSION: This study highlights two risk factors for stasis ulcer: artificial knee joints (in the univariate analysis only) and HF. An increase in leg oedemas is probably an important mechanism but we suggest the role of hypoxaemia in patients with isolated left HF. We advise an internist approach in the management of venous leg ulcers, which we prefer to name stasis ulcers, before having ruled out a general disease. In particular, we recommend a consultation with a cardiologist in the event of doubt.

[Pulmonary complications of transfusion (TACO-TRALI)]. / Complications pulmonaires de la transfusion (TACO-TRALI).

Pulmonary oedemas occurring during or after a blood transfusion appear as the most frequent serious immediate incidents in the French hemovigilance database. They include transfusion-associated circulatory overload (TACO) and transfusion-related acute lung injury (TRALI). TACO are a major cause of transfusion-related death in France. TRALI are more and more recognized and notified. In no case, pooled fresh frozen plasma (100 donations) treated with solvent-detergent were involved in French TRALI cases. A logigrame will allow hemovigilance officers to better classify pulmonary oedemas in e-fit, the French hemovigilance database.

[Evolution of transfusionnal requirements in hematology]. / Evolution des besoins transfusionnels en hématologie.

Predicting transfusion requirements relies both on epidemiology and therapeutic changes in hematology. The incidence rate of B-cell neoplasias especially non-Hodgkin lymphoma and myelodysplasia is increasing. Chemotherapy related myelodysplasia will reflect the improvement of solid tumor prognostic in the future. For myelodysplasias, therapeutic changes including oral iron chelators and more intensive transfusion policies will likely result in an increase of PRC requirements, a situation shared by sickle-cell disease.

[Transfusion in haematology]. / Transfusion en hématologie.

In the field of oncohematology, the rationale for the use of blood transfusion relies both on the proliferative advantage of the transformed clone over the others and on hematologic toxicity of chemotherapy. In France, transfusion thresholds are established by a consensus conference organized by the Agence française de sécurité sanitaire des produits de santé (Afssaps), the French health products safety agency: 80g/l for PRC and 10G/l for platelets concentrates in patients without additional hemorragic risk factors. For FFP especially in TTP, thresholds are more patient-related. Transfusion for sickle cell patients remains a scientific challenge.

[Evaluation of adherence to the regulations for declaration of notification of transfusion reactions with fever and chills. A study of the Association Inter-Régionale du Sud-Est d'Hémovigilance (AIRSEH)]. / Evaluation de la conformité à la réglementation des déclarations d'incidents transfusionnels pour frissons-hyperthermie dans des établissements de santé du sud-est de la France (groupe AIRSEH).

Febrile non-hemolytic transfusion reactions (FNHTR) are the most frequently reported acute adverse effects of blood products, and should be notified within 48 h according to the hemovigilance regulation. In order to study the conformity of these notifications and to search for factors associated with non-conformity, we retrospectively studied all FNHTR notified by voluntary centers of the AIRSEH group from 1st September 1994 to 31st December 1999. Seven hundred and sixty-one FNHTR were registered by 10 centers, most of them were benign (grade 1); 67.8% were non-conform. The non-conformity was associated with the number of biological investigations performed (median number, respectively, 4.24 and 2.94--P = 0.038--in non-conform and conform notifications--P = 0.038) in univariate analysis. Using a logistic regression model, center and severity were the only two factors significantly associated with non-conformity. Different center practices, and in particular the interface between the hospital and the blood bank, may be responsible for the effect center. Moreover, the non-conformity concerns first of all benign FNHTR. A stronger separation between alert and epidemiological surveillance is proposed in order to improve the notifications' conformity.