[Distinctive tabard: A solution to avoid work interruptions in the blood transfusion?] / Gilet distinctif : une solution pour éviter les interruptions de tâche dans le domaine transfusionnel ?

AIM: In the blood transfusion, the interruption of work (IW) can lead to serious incidents and/or adverse effects. The aim of our work is to evaluate the wearing of a distinctive tabard in the IW. METHODS: Several voluntary departments from 5 establishments of health in the Center-Val de Loire region have participated in this work from October to December 2017. The survey was given to nurses (identified by the first three letters of the first name) before and after wearing the tabard (for 2 months) for all transfusions realized in their respective department. We matched the survey by nurse and by department. The Student t test was conducted to evaluate the contribution of the tabard during IW. RESULTS: One hundred and one survey (31 in surgery, 70 in medicine) were collected before wearing and 91 (27 in surgery, 64 in medicine) after wearing the tabard. Before wearing the tabard, the number of nurse having or not IW was the same. After wearing the tabard, 42% had an IW and 58% didn't had IW (P=0.43; χ2). Sixty-four surveys were matched (27 exclusions : different IDEs) according to IW before and after wearing the tabard. The wearing of the tabard allows a statistically significant decrease IW (z=2.61, P=0.009, student test). CONCLUSION: Wearing the tabard during blood transfusions is statistically significant means of reducing IW. It's probably a first solution to increase the security of the act, to which must be added other means (poster, phone management, poster and information campaign). It's easier to eliminate IW than to manage.

Unacknowledged adverse transfusion reactions: Are they a mine to dig?

OBJECTIVES: Haemovigilance has long tried to characterize and understand transfusion reactions in order to prevent them. Unacknowledged ones are now a minority but they question us. Are they the result of incomplete clinical setting and/or insufficient medical reasoning, or can they contain real new entities we have not yet understood? MATERIAL AND METHODS: Ten volunteer experts reviewed 30 recent unacknowledged cases. Their diagnostic propositions were compared with data issued from a five-year repository we have analysed in terms of statistical links between clinical signs and diagnoses. RESULTS: Experts' opinions are only quite unanimous in 60% of the cases, and the proposed diagnosis remains unacknowledged in 53%. Repository comparison shows that signs like pain or digestive symptoms are far more frequent in unknown reactions. However, it is more the absence of some other signs which drives to that conclusion, in a default diagnosis mechanism. CONCLUSION: Errors in transfusion reactions medical analysis are rare. Unacknowledged cases are more often linked to poor or unspecific clinical setting. But a particular attention must be paid with infrequent diagnoses which are far less characterised, like metabolic complications. Pain high occurrence in unknown cases also commands us to go further in the characterisation of acute pain transfusion reaction diagnosis, which is suggested by some authors.

[Delayed adverse reactions to blood donation: From haemovigilance data to specific studies]. / Les effets indésirables retardés chez les donneurs de sang : des données de l'hémovigilance aux études spécifiques.

OBJECTIVES: Delayed adverse reactions to blood donation occur after the donor left donation site. Their intrinsic gravity and possible complications can be increased by the fact the donor is alone. This can also increase bad memories, leading to a donation giving up. Blood transfusion centre is only aware in case of donor feedback, hence an event underrating. We choose to compare our data upon delayed adverse donor reactions with those we could find in past studies. METHODS: A first data level comes from French haemovigilance data while serious adverse reactions declaration is mandatory. But a second level can be reached using blood transfusion centre computerized data because all the donation reactions are saved whatever the gravity is. In both cases, delayed reactions are only those reported by donors. We try to make an exhaustive search of specific studies upon the real delayed reactions incidence so as to compare with our data. RESULTS: There were 1957 serious adverse reactions declared in our regional haemovigilance database between 2011 and 2015: 49 % occurring during donation, 40 % after it but before donor departure, and 11 % delayed events. There were 16,050 adverse reactions recorded during the first trimester of 2016 in mainland France, with 2.7 % delayed ones. Proportion of delayed events rises when gravity rises, until 27.6 % for the most serious ones. It varies between 2.2 % and 2.7 % for vasovagal reactions, haematomas, and other local reactions, and reaches 16.2 % for other general reactions. Data found in other studies with a spontaneous donor notification are of the same kind. But four studies soliciting specifically donor notification give a dramatically higher delayed reactions incidence, with an understatement greater than three out of four. Moreover, these studies found a majority of delayed reactions, which are not included in haemovigilance like fatigue or bruising. CONCLUSIONS: Occurrence of a delayed donor reaction is clearly underrated in standard haemovigilance. It remains to be seen whether it have the same impact on donor return as immediate reactions. Considering that delayed reactions are much larger, it might be interesting to take them into account in the evaluation of strategies dedicated to lower immediate reactions.

EFS Centre-Atlantique donor's biobank: Ten years of samples usage.

INTRODUCTION: The French Establishment of Blood Centre Atlantique (EFSCA) is one of the French regional blood transfusion centers. Donor's biobank is a mandatory activity leading to the storage of biological samples taken from the blood donor. Samples of each blood donation are preserved for a 5-year period at Châteauroux in the form of two straws of 500microliters stored in liquid nitrogen. The aim of this study was to analyze the samples usage by studying quantitative, qualitative and economic criteria. MATERIAL AND METHOD: We analyzed all the requests of stored blood samples from 2005 to 2014. They were coming either from the blood donor qualification laboratory (BDQL), in order to perform complementary tests, or from hemovigilance inquiry. RESULTS: Among the blood donation samples, 2,144,636 (whole blood, plasma or platelets apheresis) were preserved during these ten years. During this period, 548 (0.025%) requests for samples were received; 78% were in relation with a request of the BDQL and 22% in relation with a request of hemovigilance. For the straws, the mean exit delay with regard to the blood donation date was 11.5 months (2-55). The cost of samples exit includes only working hours of a laboratory technician. On average, the annual working time dedicated to this activity was 23h. Also, the average price for one-year issuing activity was 620.31 euros. CONCLUSION: In our study, the donor's biobank was little used. The part of hemovigilance was weak but essential for the blood safety.

Patient labels as a quality indicator of identitovigilance in French hospitals.

INTRODUCTION: Identity risk is frequent and serious. Between 2007 and 2010, 25.6% of 1572 serious adverse events declared in France are related to identitovigilance. No regulation clearly defines an ideal patient label even when a delivery refusal is applied in case of absent or incomplete identity (absence of surname and/or first name and/or birth date). The aim of the study was to draw up the current situation of patient labels in hospitals connected with our blood transfusion center and being used for blood products delivery and immuno-hematology analyses. MATERIALS AND METHODS: We defined an ideal label with 5 items which must be present and clearly identified: surname, usual or marital name, first name, birth date and sex. It contains also an identifier, if possible with a bar code. We compare it with labels used in our hospitals. RESULTS: Only 22% (17/76) had a patient label in compliance with our ideal label. Most of the items, even if they were not clearly identified on the label, were present. The surname was present and clearly indicated in 75% of cases (57/76). In approximately 50% of cases, there was a barcoded permanent and/or stay identifier. CONCLUSION: Our results, with only 22% of labels considered as 'ideal', show all the work which remains to be done. A temporary solution can be the elaboration by hospitals of an identification guide of their present labels.

Blood donors--Serious adverse reactions (SAR) 2010-2014 EFS Châteauroux, France.

BACKGROUND: In 2013, the national French incidence of serious adverse reactions (SAR) was 155.7 per 100,000 donations and 82% of SAR were grade 2 (French classification of SAR related to blood donors) AIMS: The purpose of our study was to describe the profile of blood donator candidate which had a SAR in our center. METHODS: The study contains all the SAR superior to grade 1 occurred on the site EFS Châteauroux (site and mobile blood collection) from January 2010 to October 31, 2014. We analyzed 37 parameters from the e-fit files (e-site French blood vigilance) and In-log software. RESULTS: We identified 82 SAR for 72,553 blood donations (incidence: 113.02 SAR per 100,000 donations). Forty-one men and 41 women, middle age 39 years (18-66). Average height: 1.68 m (1.49-1.85); average weight: 68 kg (50-98); body mass index (kg/m(2)): 24,13(18.6-31.9). All donors were Caucasian and 30% unemployed. We found 74 vasovagal syncope (VVS), 5 hematomas, 2 arterial injuries and an adverse reaction to citrate. In 90%, the SAR was immediate and of grade 2 in 85% of cases. Thirty-seven percent of SAR were first donation in connection with whole blood in 87% of cases. Regarding the seniority of donors, the number of average donations (whole blood, plasma, platelets) was 16.5. An SAR determined the stop of blood donation in 65% of cases with nearly 80% stoppage if it was a first donation. Seventy-three percent of SAR as a VVS took place during blood collection or within 5 minutes following the end of the donation. Sixty-one percent were men. Forty-four percent of cases were a first donation and 83% occurred in mobile blood collection. Average age was 36 years. The result was a permanent stop of all type of donations in 76% of cases. Twenty-seven percent of SAR as a VVS took place beyond 5 minutes after the end of the donation. Seventy-five percent were women. Thirty percent of cases were a first donation and 95% of SAR occurred in mobile blood collection. Average age was 42 years. The result was a permanent stop of all type of donations in 40% of cases. CONCLUSIONS: When the SAR as a VVS occurs during or within 5 minutes following the end of the donation, it leads to a permanent stop of any type of donation in 76% of cases.

Effectiveness of interferon plus ribavirin combination in the treatment of naive patients with hepatitis C virus type 5. A French multicentre retrospective study.

AIM: To assess the rate of sustained virological response in naïve hepatitis C virus-type 5 patients treated by standard interferon or pegylated-interferon [corrected] (peg-interferon) and ribavirin combination for 48 weeks. PATIENTS AND METHODS: A total of 87 hepatitis C virus patients were included from 12 centres in France; 28 patients received interferon plus ribavirin and 59 were treated with peg-interferon plus ribavirin. RESULTS: Baseline characteristics were: mean age 58 +/- 11 years, sex ratio 1, 66% had metavir fibrosis score >or=F2, 21% were cirrhotics and 53% had pretherapeutic viral load >or=800,000 IU/mL. Sustained virological response was achieved in 64% and 58% of hepatitis C virus-5 patients treated with interferon and peg-interferon, respectively (NS). In adherent patients, sustained virological response was obtained in 75% of patients. Sustained virological response in hepatitis C virus-5 patients (60%) was significantly higher than sustained virological response in hepatitis C virus-1 patients (37%) (P = 0.0499) and not significantly different from sustained virological response in hepatitis C virus-2-3 patients (63%) (P = 0.8098). CONCLUSIONS: Combination therapy is effective in 60% of hepatitis C virus-5-infected patients. Sustained virological response seems better in hepatitis C virus-5 patients than in hepatitis C virus-1 patients, and is similar to that of hepatitis C virus-2-3 patients. More studies are needed to determine optimal duration of treatment in hepatitis C virus-5 patients.

Respective value of alkaline phosphatase, gamma-glutamyl transpeptidase and 5' nucleotidase serum activity in the diagnosis of cholestasis: a prospective study of 80 patients.

We studied the value of alkaline phosphatase (AP), gamma-glutamyl transpeptidase (GGT), and 5'-nucleotidase (5'-NU) activities in the diagnosis of intrahepatic (IHC) versus extra-hepatic cholestasis (EHC). Eighty patients were included prospectively. All presented with cholestasis as defined by a concomitant increase in at least two of three cholestatic enzymes (AP, GGT, 5'-NU), a low cytolytic ratio (alanine aminotransferase/AP [xN/xN] < or = 5), and no evidence for associated liver tumor. We compared 43 patients with IHC due to chronic liver disease to 37 patients with EHC due to main bile duct obstruction. Fasting blood samples for activity determination (AP, GGT, 5'-NU) were taken before performing liver biopsy in cases of IHC and before endoscopic or surgical management in cases of EHC. Enzyme activities were compared using univariate and multivariate analysis. AP (276 IU/L [35-3,140] vs. 123 IU/L [37-699]: p < 0.0001), GGT (595 IU/L [98-5,200] vs. 211 IU/L [38-925]; p < 0.0001), and 5'-NU (32 IU/L [10-142] vs. 16 IU/L [4-107]: p < 0.0003) were significantly higher in EHC when compared to IHC. Only in GGT and 5'-NU activities were independent variables significantly linked to the mechanism of cholestasis. In IHC, the ratio GGT/5'-NU (xN/xN) was significantly lower than in EHC (2.8 [0.7-7.2] vs. 3.7 [1.8-10.5]: p < 0.006). A threshold of GGT/5'-NU < 1.9 had a sensitivity of 40% and a specificity of 100% for the diagnosis of IHC. Although such hepatobiliary enzymes cannot be regarded as diagnostic, they can provide useful information to orientate the clinician in the diagnosis of cholestasis.

Insulin resistance-associated hepatic iron overload.

BACKGROUND & AIMS: Hepatic iron overload has been reported in various metabolic conditions, including the insulin-resistance syndrome (IRS) and nonalcoholic steatohepatitis (NASH). The aim of this study was to show that such hepatic iron overload is part of a unique and unrecognized entity. METHODS: A total of 161 non-C282Y-homozygous patients with unexplained hepatic iron overload were included. We determined the age; sex; presence of IRS (1 or more of the following: body mass index of >25, diabetes, or hyperlipidemia); serum iron tests and liver iron concentration (LIC; reference value, <36 micromol/g); liver function test results; C282Y and H63D HFE mutations; and liver histological status. RESULTS: Patients were predominantly male and middle-aged. Most (94%) had IRS. Transferrin saturation was increased in 35% (median, 42%; range, 13%-94%). LIC ranged from 38 to 332 micromol/g (median, 90 micromol/g), and LIC/age ratio ranged from 0.5 to 4.8 (median, 1.8). Allelic frequencies of both HFE mutations were significantly increased compared with values in normal controls (C282Y, 20% vs. 9%; H63D, 30% vs. 17%), only because of a higher prevalence of compound heterozygotes. Patients with no HFE mutations had similar degrees of iron overload as those with other genotypes, except for compound heterozygotes, who had slightly more iron burden. Steatosis was present in 25% of patients and NASH in 27%. Portal fibrosis (grades 0-3) was present in 62% of patients (grade 2 or 3 in 12%) in association with steatosis, inflammation, and increased age. Sex ratio, IRS, transferrin saturation, and LIC did not vary with liver damage. Serum ferritin concentration, liver function test results, and fibrosis grade were more elevated in patients with steatosis and NASH than in others, but LIC and allelic frequencies of HFE mutations were similar. CONCLUSIONS: This study shows that patients with unexplained hepatic iron overload are characterized by a mild to moderate iron burden and the nearly constant association of an IRS irrespective of liver damage.

[Importance of liver puncture biopsy and endoscopic retrograde cholangiography in patients with chronic anicteric unexplained cholestasis. A retrospective study in 79 patients]. / Intérêt de la ponction-biopsie hépatique et de la cholangiographie rétrograde endoscopique chez les malades ayant une cholestase chronique anictérique inexpliquée. Etude rétrospective chez 79 malades.

AIM: To determine the diagnostic value of systematic liver needle biopsy and endoscopic retrograde cholangiography in patients with unexplained chronic anicteric cholestasis. METHODS: Seventy nine patients presented with anicteric cholestasis for over 6 months as defined by: a concomitant increase in at least 2 of 3 cholestatic enzymes (GGT, alkaline phosphatase, 5'nucleotidase); a low cytolytic ratio (ALT/AP (xN/xN) < or = 5); and negative test results (normal ultrasound scan; no antimitochondrial antibodies, viral, drug-induced, or toxic hepatitis, or known ulcerative cholitis). Based on liver biopsy and endoscopic retrograde cholangiography, 5 groups were determined; group A: normal liver biopsy and endoscopic retrograde cholangiography; group B: primary sclerosing cholangitis with histological biliary lesions; group C: primary sclerosing cholangitis with normal histology; group D: histologic biliary lesions alone; group E: other (aspecific histologic lesions, isolated anomalies of intrahepatic bile ducts on endoscopic retrograde cholangiography). RESULTS: Diagnosis of cholestasis was fortuitous in 43% of cases. Group A: 5 patients had normal liver biopsy and endoscopic retrograde cholangiography; group B (10 patients): 5 with destructive cholangitis, 5 with degenerative cholangitis, associated with portal fibrosis in 90%; group C: none of the patients had primary sclerosing cholangitis with normal histology; group D: 39 patients {idiopathic ductopenia (1), Caroli's disease (1), benign recurrent cholestasis (1), regenerative nodular hyperplasia (4), destructive cholangitis without ductopenia (7), degenerative cholangitis (15), ductular proliferation (10)}; group E: 24 patients with aspecific histologic lesions, and one patient with isolated anomalies of the intrahepatic bile ducts on endoscopic retrograde cholangiography. CONCLUSIONS: In the present population: a) 13% presented with intense cholangitis and primary sclerosing cholangitis on endoscopic retrograde cholangiography; b) 49% presented with various histologic biliary lesions without primary sclerosing cholangitis. We conclude that in chronic anicteric cholestasis of unexplained origin, first choice work-up should include liver biopsy, and endoscopic retrograde cholangiography should only be performed when intense histologic cholangitis is observed.

Magnetic resonance iron-free nodules in genetic hemochromatosis.

OBJECTIVE: In hemochromatosis, areas of normal hepatic magnetic resonance (MR) signal intensity indicate the presence of iron-free-nodules, which are strongly suspected of being neoplastic. The goal of the study was to define the prevalence and the nature of these iron-free MR nodules at the time of diagnosis in 116 patients included in a prospective study assessing the accuracy of MR imaging (MRI) in the quantification of liver iron overload. METHODS: Seventy-nine of the 116 patients had homozygous hemochromatosis on a phenotypic basis. Fifteen-millimeter-thick contiguous slices were performed using T1- and T2-weighted gradient echo sequences with a 0.5 Tesla magnet. RESULTS: Six of 79 homozygous hemochromatotic patients had one or more MR iron-free nodules. Five of the six patients proved to have malignant tumors. Four of six iron-free nodules were hepatocellular carcinoma (5% in the hemochromatosis group and 17.5% in hemochromatotic patients with severe fibrosis). CONCLUSIONS: The present data confirm the high prevalence of liver cancer at the time of diagnosis, mainly in cirrhotic patients greater than 45 years of age, and indicate that, when performing MRI for liver iron quantification, a complete hepatic MRI examination is preferable to a simple signal measurement in patients at risk for hepatocellular carcinoma.

In patients with cirrhosis, serum albumin determination should be carried out by immunonephelometry rather than by protein electrophoresis.

OBJECTIVE: Serum albumin is a key parameter for prognosis in cirrhosis. We compared levels of serum albumin determined by both protein electrophoresis and immunonephelometry, with special reference to the Child-Pugh classification. DESIGN AND METHODS: One hundred and thirty-one patients, including 39 with cirrhosis, were included prospectively during 2 months. The aetiology of cirrhosis was mainly alcoholism (67%) and hepatitis C virus (HCV) (18%). Serum albumin was determined simultaneously by electrophoresis (Hydrasys SEBIA following protein determination by the biuret reaction) and by immunonephelometry (BECKMAN Nephelometer). Values were compared by non-parametric tests. RESULTS: For the whole population, electrophoretic and immunonephelometric values correlated (p = 0.85; P < 0.0001), but electrophoresis significantly overestimated serum albumin by a median 1.6 g/l (P < 0.0001) with a large spread in values (range, -3.9 to 12.7). Median overestimation in cirrhosis was 2.6 g/l (P < 0.0001; range, -2.0 to 10.2) and 1.0 g/l (P < 0.0001; range, -3.9 to 12.7) in patients without cirrhosis (difference, P < 0.02). For 6/39 (15.4%) patients with cirrhosis, this overestimation led to an underestimation in the Child-Pugh classification. CONCLUSION: In our experience, electrophoresis can lead to serum albumin values which are significantly different compared to those obtained by immunonephelometry. This discrepancy may lead to an incorrect Child-Pugh classification. Therefore, in the follow-up of cirrhotic patients, serum albumin should be determined by immunonephelometry.

[Epidemiology of hepatitis C virus infection in 1,304 HCV positive patients: variations according to the origin of transmission and year of diagnosis]. / Epidémiologie de l'infection virale C chez 1,304 sujets VHC positif. Variations en fonction du mode de contamination et de l'année du diagnostic.

UNLABELLED: The evolution of epidemiological data on hepatitis C virus infection is poorly documented and thus the impact of screening is difficult to evaluate. AIM: To study epidemiological variations based on the origin of transmission and the year of diagnosis of hepatitis C virus infection. METHODS: The files of all 1304 patients seen in the hepatology unit of the Rennes University Hospital were analyzed (retrospectively before and prospectively after October 1995) in relation to epidemiological features. RESULTS: Despite widespread screening which is the source of 60% of the diagnoses, the total number of new cases of hepatitis C infection per year has not increased. Compared to patients diagnosed in the first years following the discovery of the virus, patients recently identified were younger (42 +/- 14 years) and frequently drug addicts (40%). Aminotransaminases were normal in 20% of cases. The frequency of cirrhosis has declined (17%). There has been a decrease in the proportion of patients who undergo liver biopsy (50%) and treatment with interferon (one third of patients). CONCLUSIONS: The impact of screening on the number of newly treated patients seems to be lower than previously predicted.

Intrahepatic cholestasis of pregnancy: a French prospective study.

The aim of this prospective study was to analyze the characteristics of intrahepatic cholestasis of pregnancy (ICP) in a French population. From 1989 to 1995 we studied 50 consecutive pregnant women with ICP (41 single, 7 twin, and 2 triplet pregnancies) referred for hepatologic consultation. All patients suffered from pruritus and/or jaundice associated with elevated fasting serum levels of total bile acids (mean 49 micromol/L, range 7-290). No patients had concomitant liver disease and all recovered normal liver function after delivery. Overall prematurity rate was 60%: 100% in multiple pregnancies and 41% in single pregnancies. Three of 61 babies died. Systematic clinical interviews revealed that 34 patients had been treated with oral micronized natural progesterone (200-1,000 mg/d) during the current pregnancy for risk of premature delivery, including at least 32 (64%) before the onset of pruritus. Onset of pruritus was statistically earlier in patients previously receiving progesterone than in patients not receiving progesterone (217 +/- 21 vs. 240 +/- 26 days, P < .01). This was also found in the single pregnancy subgroup of patients (222 +/- 19 vs. 240 +/- 26 days, P < .05). Pruritus disappeared before delivery in 10 of 50 patients, i.e., after withdrawal of progesterone in 7 patients (only one concurrently treated with cholestyramine), after decrease in dose of progesterone in 1 patient, and spontaneously in 2 patients. During the same period, the percentage of pregnant women without ICP who had been treated with progesterone during pregnancy was statistically lower than the percentage of patients treated with progesterone before the onset of pruritus in our group of patients with ICP (36% vs. 64%, P < .01, odds ratio 3.16, 95% CI:1.29-7.80). These results suggest that orally administered progesterone might be an exogenous factor which triggers ICP in predisposed women.