Iron deficiency among French whole-blood donors: first assessment and identification of predictive factors.

BACKGROUND: The objectives of this study are to estimate the prevalence of iron deficiency (ID) among French whole-blood (WB) donors to identify factors associated with ID and to generate decision trees. STUDY DESIGN AND METHODS: A prospective National multicentre study was performed on WB donors from March 11, to April 5th, 2019. Samples were selected randomly to perform serum ferritin. ID was defined as ferritin value under 26 ng/ml. All results were stratified by sex. Factors associated with ID were analysed using multivariate logistic regression model. CART algorithm was used for decision trees. RESULTS: Eleven thousand two hundred fifty eight WB donors were included. ID was more frequent in women (39·5%) than in men (18·0%). Among 7200 repeated donors, women below 50 yo had a higher risk (OR = 2·37; [1·97-2·85] IC95) than those above 50 yo. Factors associated with ID were: haemoglobin level under the threshold at donation n-1 except for women and n-2 donation; a low mean corpuscular haemoglobin at n-1 and n-2 donations; a shorter interval since n-1 donation and between n-1 and n-2 donations except for women; and women who had given three or four times in the last year. CART algorithm defined high risk of ID subgroups within three populations of donors, new female donors, repeated male donors and repeated female donors. In these identified subgroups, prevalence of ID was up to 72·1%. CONCLUSIONS: Our study showed the high prevalence of ID among French WB donors, identified well-known and new factors associated with ID and defined algorithms predicting ID in three populations.

Noncompliance to blood donor selection criteria by men who have sex with men - Complidon 2017, France.

BACKGROUND AND OBJECTIVES: In France, blood donation deferral for men who have sex with men (MSM) was reduced from permanent to 12 months in July 2016. Assessing noncompliance (rate and reasons) with this criterion is important to maintain a high level of viral safety in blood products. MATERIALS AND METHODS: An anonymous online survey (Complidon) of a sample of blood donors was conducted in 2017. Data were post-stratified to be representative of all those who donated blood between July 2016 and December 2017. A multivariable analysis was performed to assess factors associated with noncompliance. RESULTS: Among male donors, 0·73% [95% CI: 0·63-0·83] reported having sex with men in the 12 months preceding their donation. Factors associated with noncompliance were as follows: young age, a low educational level, concerns about privacy, and better knowledge of donor selection criteria and the window period than compliant men. More than half of noncompliant MSM donors (57·6% [95% CI: 50·6-64·3]) felt that sexual orientation should not be a criterion for donation, 47·2% [95% CI: 40·4-54·0] did not disclose their male-to-male sexual relations in order to avoid being excluded from donating, 40·5% [95% CI: 34·0-47·4] reported using condoms and 21·8% [95% CI: 16·7-27·9] had the same male partner for at least 12 months. CONCLUSION: Complidon showed that compliance with blood donation criteria in MSM was high, but not optimal, especially among younger men. HIV residual risk did not increase after the implementation of 12-month deferral. Data from Complidon helped French policymakers to assess the additional HIV risk posed by increased access to blood donation for MSM.

Effectiveness of the HCV blood screening strategy through eighteen years of surveillance of HCV infection in blood donors in France.

BACKGROUND: The question of maintaining blood screening based on both Hepatitis C virus (HCV) infection antibodies (Ab) and Nucleic Acid Testing (NAT) has been raised in several countries. The French blood donor surveillance database was used to address this issue. MATERIALS AND METHODS: In France, HCV-NAT was implemented in mini pools (MP) in 2001 and in individual testing (ID) in 2010. HCV-positive donations are further investigated including detection of RNA with an alternative polymerase chain reaction assay: Amplicor HCV v2.0 (Roche; LOD95 50 IU/mL) from 2001 to 2006 and CobasTaqMan (CTM) HCV 2.0 assay (Roche; LOD95 9.3 IU/mL) since 2007. RESULTS: From 2001 to 2018, 3,058/48.8 million donations were confirmed HCV positive: 64.4% were Ab+/NAT+, 35.1% Ab+/NAT- and 0.5% Ab-/NAT+. From 2001 to 2018, the NAT yield decreased from 0.65 per million donations to 0, and NAT+ donations dropped from 77% to 46% of the total of HCV donations. 2,491/3,058 were further tested for HCV-RNA: 1,032 (816 NAT+, 216 NAT-) with Amplicor and 1,459 (897 NAT+, 562 NAT-) with CTM. Four (3 MP and 1 ID-NAT, 0.5%) of the 778 NAT negative donations had low viral loads. DISCUSSION: The decline in HCV-NAT yield cases raises the question of the relevance of NAT. Conversely, the increase in Ab+/NAT-donors, suggesting a growing number of resolved infections, argue for Ab discontinuation. In our experience, at least 0.5% of Ab+/NAT-donations had low RNA level when retested. Although the risk of viral transmission by such donations is probably low, the uncertainty associated with their infectivity goes against the removal of Ab in blood screening in our country.

French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial.

BACKGROUND: Post-trauma bleeding induces an acute deficiency in clotting factors, which promotes bleeding and hemorrhagic shock. However, early plasma administration may reduce the severity of trauma-induced coagulopathy (TIC). Unlike fresh frozen plasma, which requires specific hospital logistics, French lyophilized plasma (FLYP) is storable at room temperature and compatible with all blood types, supporting its use in prehospital emergency care. We aim to test the hypothesis that by attenuating TIC, FLYP administered by prehospital emergency physicians would benefit the severely injured civilian patient at risk for hemorrhagic shock. METHODS/DESIGN: This multicenter randomized clinical trial will include adults severely injured and at risk for hemorrhagic shock, with a systolic blood pressure < 70 mmHg or a Shock Index > 1.1. Two parallel groups of 70 patients will receive either FLYP or normal saline in addition to usual treatment. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. Secondary endpoints are transfusion requirement, length of stay in the intensive care unit, survival rate at day 30, usability and safety related to FLYP use, and other biological coagulation parameters. CONCLUSION: With this trial, we aim to confirm the efficacy of FLYP in TIC and its safety in civilian prehospital care. The study results will contribute to optimizing guidelines for treating hemorrhagic shock in civilian settings. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02736812. Registered on 13 April 2016. The trial protocol has been approved by the French ethics committee (CPP 3342) and the French Agency for the Safety of Medicines and Health Products (IDRCB 2015-A00866-43).

[Biological procedures, civil and military health facilities, and recommendations of good practice and hospital reform: the example of diabetes management]. / Actes de biologie, établissements de santé civils et militaires, recommandations de bonnes pratiques et réformes hospitalières: exemple de la prise en charge du diabète.

In the context of implementing hospital reforms, the objective of this work was to compare practice in relation to evidence-based guidelines and recommendations for good practice in diabetes screening and management. Laboratory test consumption was determined for patients hospitalized for diabetes in 2005 in three public hospitals (one civilian, two military) taking care of diabetic patients and performing related biological tests. For the 395 admissions in these three hospitals during 2005 [Diagnosis-related group (DRG) 10M02V "Diabetes, age 36 to 69 years without co-morbidity"], the average length of stay and the number of biological acts ["B"] performed were lower than those given by the French national health cost study scale and by the Montpellier University Hospital database. In terms of qualitative coherence between the guidelines for treatment and the recommendations, the total number of biological acts ["B"] is higher than if one were to strictly apply the good practice suggested by the French Health Authority. These three hospitals have and apply different guidelines for practice in the area of diabetes management. The implementation of reforms such as DRG-based payment scales may be an additional leverage to ensure that the recommendations of best practices are effective. Improved methods and tools for data collection and monitoring are essential, especially for estimating revenue and expenditure.