[The blood donors' haemovigilance in France]. / L'hémovigilance des donneurs de sang en France.

This work aim to present the descriptive analysis of serious adverse reactions in donors (dSAR's), which were notified in 2010 and 2011 in the French national haemovigilance database "e-FIT" (Internet secured haemovigilance reporting system). Some data, which are necessary for this analysis, also come from the regional haemovigilance coordinators' reports (RHC). The other parts of haemovigilance in the context of donation, without donors adverse reactions, such as post-donation information (PDI), adverse events occurred in the blood collection steps of the transfusion chain and epidemiology are not subject to this work analysis. This work shows that the quality of the data gradually improved since the setting up of the notification system of dSAR's. These data are particularly rich in learning lessons, but are still improving. It allows us to confirm that donor's safety, blood components quality, while preserving the blood components self-sufficiency in France, remains a priority. For these reasons, it is important to continue this haemovigilance awareness and to implement necessary actions that would be required for the protection of the donor's health and comfort during donation.

[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.

[Transfusion transmitted bacterial infectious (TTBI) with blood component accountability score 2: Retrospective analysis of the French e-fit database 2000-2007. Groupe de travail­validation des IBTT (Working group for validation of transfusion-transmitted bacterial infections)]. / Les infections bactériennes transmises par transfusion avec imputabilité 2 du PSL : analyse rétrospective de la base e-FIT de 2000 à 2007.

PURPOSE OF THE STUDY: Transfusion transmitted bacterial infection is an adverse reaction occurring in a patient during blood transfusion and due to the presence of bacteria in the blood component. For each transfusion transmitted bacterial infection suspicion, clinical and biological investigations should allow to either affirm the accountability of the transfused product in the occurrence of the infection (accountability score 4) or exclude it (accountability score 0). However, among 60,175 adverse reaction sheets extracted from the French e-FIT database (AFSSAPS), 143 are classified as transfusion transmitted bacterial infection diagnosis and 97 of them show a score of accountability 2 (possible). This study aims to analyze these 97 adverse reaction sheets and search for the reasons that led the haemovigilance network actors not to refine the degree of accountability in line with an exclusion or a confirmation of transfusion origin. METHOD: During collective reading sessions, each adverse reaction sheet among the 97 extracted was re-analyzed with an accountability criteria grid, built beforehand, and proposed in the technical guide sheet for transfusion transmitted bacterial infection (e-Fit AFSSAPS). RESULTS: Among the 97 analyzed adverse reaction sheets with a score accountability of 2: 12.4 % were considered as "non-analysable"; 54% were reclassified in another diagnosis category: non haemolytic febrile reaction (n=12), unknown diagnosis (n=17); patient infection before transfusion (n=23); blood component's "smear" (n=9); retrograde contamination of blood component (n=5). Finally, only 18.5% adverse reaction sheets (n=18) were maintained with a true diagnosis of transfusion transmitted bacterial infection an accountability score of 2. These cases were in agreement with those described in number 2, 3 or 4 in the annex sheet "Fiche Technique TTBI". 70% of adverse reaction sheets reclassified under another diagnosis as transfusion transmitted bacterial infection had been declared between 2000 and 2004. In order to improve transfusion transmitted bacterial infection suspicions diagnosis approach and to guide the French haemovigilance network in the investigations following a transfusion transmitted bacterial infection suspicion, the group propose recommendations after each adverse reaction sheets category analysis. CONCLUSION: The improvement measures taken as part of the French haemovigilance declaration framework allowed to perfect the data quality of transfusion transmitted bacterial infection. Progresses are still to be made to improve clinical and biological declaration, in order to precise the accountability of a blood component in the occurrence of an adverse transfusion transmitted bacterial infection effect. Tracking transfusion transmitted bacterial infection notifications by a group of experts at the national level is still recommended.

[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.

[Evaluation of the organization of pre and post transfusion screening of viral infection markers in blood recipients in France in 2001]. / Evaluation de l'organisation du dépistage sérologique pré- et post-transfusionnel en France en 2001.

In France, data collection related to blood recipient's viral infectious disease markers pre and post-transfusion is a legal requirement for hospitals. Our study aimed to evaluate the actual modalities of this extensive screening in 2001, six years after the Ministry of health issued recommendations. A questionnaire was sent to the haemovigilance correspondents in hospitals having transfused labile blood products (LBP) in 2001. A total of 1463 hospitals having transfused 85% of LBP in France responded. 82.4% of hospitals have written guidelines for pre-transfusion screening of viral markers, mainly for HIV and hepatitis C. A frozen repository storage is held by 23.9% of hospitals with storage durations between 1 to 40 years. 84% of hospitals have written guidelines for post-transfusion screening. The test prescriptions are mostly done by physicians from clinical services and they include in more than 80% of cases, HIV and HCV markers. Only 12% of hospitals recontact the patient in case of a no show. Even though 77.5% of responding hospitals have labile blood products recipients follow up processes, their effectiveness remains quite low, only 16% of recipients having test results available at the hospital.

[Efficiency of hepatitis C virus screening before and after blood transfusion]. / Evaluation médicoéconomique du suivi sérologique péritransfusionnel du virus de l'hépatite C.

UNLABELLED: Efficiency of a viral hepatitis C screening strategy before and after blood transfusion has to be evaluated. METHODS: Four screening strategies were virtually applied to the population of transfused patients at Rouen University Hospital during 1996 and then compared : the first without any systematic HCV screening test; the second with systematic testing both before and 3 months after transfusion; the third with systematic testing both before and 6 months after transfusion ; the last defined as systematic testing before transfusion only. The efficacy (i.e. number of positive tests), the efficiency (i.e. average cost per positive test) and the marginal costs of moving from a strategy to another one were assessed using decision analysis. RESULTS: The efficacy of systematic screening test before transfusion only (361 per positive test), systematic testing both before and three months after (523 per positive test) or six months after (488 per positive test) transfusion was similar, but the efficacy of the strategy without any systematic screening test (385 per positive test) was lower. The systematization of screening test both before, and three months, or 6 months after transfusion lead to a marginal cost of 619 , and 559 per positive test respectively. The systematization of testing before transfusion only lead to a marginal cost of 343 per positive test. Adding systematic testing after transfusion lead to a marginal cost of 5824 per positive test. CONCLUSION: Systematic screening tests before transfusion only can be considered as the most efficient strategy.

[Evaluation of pre- and post-transfusion serological screening in France in 2001]. / Evaluation du dépistage sérologique pré- et post-transfusionnel en France en 2001.

Screening of labile blood products recipients for HIV and HCV has been performed in France since a government recommendation was issued in 1996. It has been designed to get transfusion related contamination of recipients through pre- and post-transfusion serological tests. Since then, residual risk has decreased dramatically and it was suspected that recommendations might sometimes be ignored. A nationwide survey has been done to measure the real screening rate and its cost efficacy ratio. In addition accuracy of tracability and recipients mortality has also been evaluated. A random sample of 1115 labile blood products among all the 1203 378 distributed during first semester of 2001 in France has been drawn. They have been matched with test results obtained in hospital files. Tracability has been considered accurate if name, surname and birth date of recipients were exactly the same both in hospital file and in the file of the Etablissement Français du Sang. A total of 1092 hospital files has been retrieved. Pre transfusion HIV and HCV tests have been performed in 58.5 % of cases, 95 % CI [55.6-61.5], and post-transfusion tests in 30.5 % [28.5-35.5] of cases. Only 19.5% [16.6-22.6] of recipients, not known to be dead 6 months after transfusion, have had both pre and post-transfusion tests. No HIV or HCV contamination has been notified by the Haemovigilance network during the same period. Accuracy rate of tracability was 96.25% [94.9-97.3]. Furthermore 35.8% [33-38.7] of recipients were found dead within 6 months after transfusion. A logistic regression analysis showed that the hospital area, the hospital size (more than 300 beds) and the annual amount of blood bags transfused in it (less than 5000) were factors independently associated with having a full pre and post-transfusion screening. Currently, the screening program may detect 0.14 cases of HIV and 0.05 HCV transfusion related contamination of recipient every year. The total cost of this program is about 20 million euro and the cost per case exceeds 110 million euro. The program will be of no use in case of an emerging transmitable disease. This program does not comply to any evaluation criteria of screening programs and its cost efficacy ratio is very poor.

Evaluation of the impact of information about treatment-related risks in patients receiving blood-derived or recombinant medications.

The aims of the study were to evaluate the impact of a written information about treatment related risks in patient receiving blood derived or recombinant medications. Haemophiliac patients and patients with constitutional or acquired immune deficiencies are concerned by this treatment and these information. Our objectives are to evaluate the efficacy of the written information, the knowledge of the patients about these medications and the psychological, emotional impact if these information. The study is based on questionnaires which specified how the patient treat bleeding episodes, their knowledge about viral safety of blood products, the patient's perception of his or her health status and relationship with the physician. Psychological and emotional status are evaluated with the Hospital Anxiety and Depression Scale. The results show the difficulty to inform patients: if the information generate only limited anxiety in patients with haemophilia or immune deficiencies, we observe that the delivery of a written information got a mediocre effect on overall knowledge. We think that this information must be appropriate for patients and be communicated orally within the patient-physician relationship.

A retrospective study on chemical and radioactive synovectomy in severe haemophilia patients with recurrent haemarthrosis.

Between 1970 and 1994, 116 chemical and 90 radioactive synovectomies were performed in 107 patients with severe haemophilia and two with type 3 von Willebrand's disease. The products used were osmic acid (OA) in 100 cases, 90-Yttrium in 35 cases, 186-Rhenium in 48, 169-Erbium in two, hexacetonide triamcinolone in 16 and radioactive gold in five cases. The use of radioactive colloids is not allowed in France in patients under 15 years of age. Twenty-nine patients had more than one synovectomy per joint. All patients were evaluated for 6 months post-synovectomy, using both a clinical and a radiological score. Six months after synovectomy, a good or excellent result was obtained for 81% of the joints treated with isotopes, compared with 44% of those treated with OA, P<0.001. This superiority of isotopes over osmic acid was still observed after 6 months for the 89 joints that were re-evaluated, with follow-up ranging from 1 to 9 years. It was possible to calculate a radiological score in 84 cases. With OA the best results were from the joints with the lowest scores pre-synovectomy (<7). No correlation could be established between the clinical and the radiological scores, due to the small size of the sample. In summary: (1) chemical and radioactive synovectomy are simple and safe procedures for haemophilic arthropathy, (2) in our series, after 6 months the efficacy of isotopic synovectomy was greater than that of chemical synovectomy, and this benefit seems to persist after 6 months, and up to 9 years in the group of patients with longer-term follow-up.

Nonsurgical synovectomy in the treatment of arthropathy in Von Willebrand's Disease.

Von Willebrand's disease is the most common inherited bleeding disorder, with an overall prevalence in the general population of 0.8% to 1.3%. Hemarthrosis occurs mainly in the severest forms of the disease (type III), with a frequency of 3.5% to 11%, and can cause severe arthropathy similar to that seen in hemophilia. We retrospectively reviewed our experience with nonsurgical synovectomy in the treatment of recurrent hemarthrosis with arthropathy in patients with von Willebrand's disease. Four of our six patients had type III disease and the remaining two had type II disease. The age range was 13 to 63 years. The frequency of hemarthrosis prior to synovectomy was one to four per month. One (n = 2) or both (n = 1) knees were treated in 4 cases, one (n = 1) or both (n = 1) ankles in 3 cases and an elbow in one case. We used yttrium 90 in a dose of 5 mCi for one knee, rhenium 186 in a dose of 2 mCi for two ankles and the elbow and osmic acid for two knees and one ankle. Clinical and radiological results were evaluated six months after synovectomy using the World Federation of Hemophilia score. Radiologic lesions remained stable and clinical manifestations improved in every case (p < 0.05). Five patients achieved a complete remission. Safety was satisfactory. The clinical efficacy of synovectomy done, using radiocolloids or osmic acid in arthropathy due to von Willebrand's disease, seems similar to that in hemophilia.

Clinical management of patients with von Willebrand's disease with a VHP vWF concentrate: the French experience.

Part of the French clinical experience using the solvent/detergent (S/D) treated VHP von Willebrand factor (vWF) concentrate (LFB, Les Ulis, France) characterized by a high vWF:RCoF specific activity and a low factor VIII (FVIII) content is reported. Since 1989 this concentrate has been routinely used in clinical practice taking into account the vWF:RCoF given by the manufacturer. Seventy-five patients with von Willebrand disease (type 1: 42, 2A: 11, 2B: 5, 2N: 6, 3: 4, acquired: 7) were treated on 99 occasions either to control spontaneous bleedings (15) or to prevent haemorrhagic risks associated with minor (< 5 days of treatment) (48) or major (5 days of treatment) (36) surgery including seven knee or hip-replacements. Forty lots of concentrate were used containing 58 +/- 13 U mL-1 vWF:RCoF with less than 10 units of FVIII per 100 units vWF:RCoF. Patients with type 2N were analysed separately. With the exception of gastro-intestinal bleedings, spontaneous bleedings were generally stopped after few infusions of 40-47 U kg-1 vWF:RCoF. Patients having more than 20 U dL-1 FVIII were treated on 54 surgical occasions with one preoperative infusion (51-55 U kg-1 vWF:RCoF) which allowed an increase in FVIII concentration to a mean level of 67-88 U dL-1. Patients with less than 20 U dL-1 were either treated with two preoperative infusions of vWF, 12 or 24 h apart (11 cases) or received a FVIII injection immediately after the preoperative infusion of vWF (10 cases). During the postoperative period vWF alone (30-35 U kg-1 vWF:RCoF) allowed FVIII to be kept at a mean level of 118-138 U dL-1 not exceeding 180 U dL-1. Patients with type 2N were treated taking in account only their baseline FVIII concentration. No haemorrhagic complications occurred in any of the patients. Thus it was found to be feasible and practical to manage replacement therapy in patients with von Willebrand disease (whatever the type or the circumstances) on the basis of the vWF:RCoF activity of the concentrate.