Tranexamic acid for the prevention of blood loss after cesarean among women with twins: a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery randomized clinical trial.

BACKGROUND: Although prophylactic tranexamic acid administration after cesarean delivery resulted in a lower incidence of calculated estimated blood loss of >1000 mL or red cell transfusion by day 2, its failure to reduce the incidence of hemorrhage-related secondary clinical outcomes (TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial) makes its use questionable. The magnitude of its effect may differ in women at higher risk of blood loss, including those with multiple pregnancies. OBJECTIVE: This study aimed to compare the effect of tranexamic acid vs placebo to prevent blood loss after cesarean delivery among women with multiple pregnancies. STUDY DESIGN: This was a secondary analysis of the TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery trial data, a double-blind, randomized controlled trial from March 2018 to January 2020 in 27 French maternity hospitals, that included 319 women with multiple pregnancies. Women with a cesarean delivery before or during labor at ≥34 weeks of gestation were randomized to receive intravenously 1 g of tranexamic acid (n=160) or placebo (n=159), both with prophylactic uterotonics. The primary outcome was a calculated estimated blood loss of >1000 mL or a red blood cell transfusion by 2 days after delivery. The secondary outcomes included clinical and laboratory blood loss measurements. RESULTS: Of the 4551 women randomized in this trial, 319 had a multiple pregnancy and cesarean delivery, and 298 (93.4%) had primary outcome data available. This outcome occurred in 62 of 147 women (42.2%) in the tranexamic acid group and 67 of 152 (44.1%) receiving placebo (adjusted risk ratio, 0.97; 95% confidence interval, 0.68-1.38; P=.86). No significant between-group differences occurred for any hemorrhage-related clinical outcomes: gravimetrically estimated blood loss, provider-assessed clinically significant hemorrhage, additional uterotonics, postpartum blood transfusion, arterial embolization, and emergency surgery (P>.05 for all comparisons). CONCLUSION: Among women with a multiple pregnancy and cesarean delivery, prophylactic tranexamic acid did not reduce the incidence of any blood loss-related outcomes.

High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial.

BACKGROUND: Vitamin D supplementation has been proposed as a treatment for Coronavirus Disease 2019 (COVID-19) based on experimental data and data from small and uncontrolled observational studies. The COvid19 and VITamin d TRIAL (COVIT-TRIAL) study was conducted to test whether a single oral high dose of cholecalciferol (vitamin D3) administered within 72 hours after the diagnosis of COVID-19 improves, compared to standard-dose cholecalciferol, the 14-day overall survival among at-risk older adults infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). METHODS AND FINDINGS: This multicenter, randomized, controlled, open-label, superiority trial involved collaboration of 9 medical centers in France. Patients admitted to the hospital units or living in nursing homes adjacent to the investigator centers were eligible if they were ≥65 years, had SARS-CoV-2 infection of less than 3 days, and at least 1 COVID-19 worsening risk factor (among age ≥75 years, SpO2 ≤94%, or PaO2/FiO2 ≤300 mm Hg). Main noninclusion criteria were organ failure requiring ICU, SpO2 ≤92% despite 5 L/min oxygen, life expectancy <3 months, vitamin D supplementation >800 IU/day during the preceding month, and contraindications to vitamin D supplements. Eligible and consenting patients were randomly allocated to either a single oral high-dose (400,000 IU) or standard-dose (50,000 IU) cholecalciferol administered under medical supervision within 72 hours after the diagnosis of COVID-19. Participants and local study staff were not masked to the allocated treatment, but the Steering Committee and the Data and Safety Monitoring Board were masked to the randomization group and outcome data during the trial. The primary outcome was 14-day overall mortality. Between April 15 and December 17, 2020, of 1,207 patients who were assessed for eligibility in the COVIT-TRIAL study, 254 met eligibility criteria and formed the intention-to-treat population. The median age was 88 (IQR, 82 to 92) years, and 148 patients (58%) were women. Overall, 8 (6%) of 127 patients allocated to high-dose cholecalciferol, and 14 (11%) of 127 patients allocated to standard-dose cholecalciferol died within 14 days (adjusted hazard ratio = 0.39 [95% confidence interval [CI], 0.16 to 0.99], P = 0.049, after controlling for randomization strata [i.e., age, oxygen requirement, hospitalization, use of antibiotics, anti-infective drugs, and/or corticosteroids] and baseline imbalances in important prognostic factors [i.e., sex, ongoing cancers, profuse diarrhea, and delirium at baseline]). The number needed to treat for one person to benefit (NNTB) was 21 [NNTB 9 to ∞ to number needed to treat for one person to harm (NNTH) 46]. Apparent benefits were also found on 14-day mortality due to COVID-19 (7 (6%) deaths in high-dose group and 14 (11%) deaths in standard-dose group; adjusted hazard ratio = 0.33 [95% CI, 0.12 to 0.86], P = 0.02). The protective effect of the single oral high-dose administration was not sustained at 28 days (19 (15%) deaths in high-dose group and 21 (17%) deaths in standard-dose group; adjusted hazard ratio = 0.70 [95% CI, 0.36 to 1.36], P = 0.29). High-dose cholecalciferol did not result in more frequent adverse effects compared to the standard dose. The open-label design and limited study power are the main limitations of the study. CONCLUSIONS: In this randomized controlled trial (RCT), we observed that the early administration of high-dose versus standard-dose vitamin D3 to at-risk older patients with COVID-19 improved overall mortality at day 14. The effect was no longer observed after 28 days. TRIAL REGISTRATION: ClinicalTrials.gov NCT04344041.

Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial.

INTRODUCTION: Patients with lower limb trauma requiring orthopaedic immobilisation may be at risk of venous thromboembolism but opinions differ about who may benefit from thromboprophylactic anticoagulant treatment.The aim of this CASTING study is to demonstrate the safety of thromboprophylaxis based on the Thrombosis Risk Prediction for patients with cast immobilisation (TRiP(cast) score with regards to the 3-month incidence of symptomatic venous thromboembolism events in low-risk patients not receiving thromboprophylaxis, as well as the usefulness of this strategy on the rate of patients receiving anticoagulant treatment in comparison to current practice. METHODS AND ANALYSIS: CASTING will be a stepped-wedge cluster randomised controlled clinical trial, performed in 15 emergency departments in France and Belgium. With their informed consent, outpatients admitted to one of the participating emergency departments for a lower limb trauma requiring orthopaedic immobilisation without surgery will be included. All centres will begin the trial with the 'observational period' and, every 2 weeks, 1 centre will be randomly assigned to switch to the 'interventional period' and to apply the TRiP(cast) score, in which only patients with a score ≥7 will receive thromboprophylactic anticoagulant treatment. The primary endpoint is the rate of clinical thromboembolic events within 90 days following the inclusion of low-risk patients not receiving thromboprophylaxis. ETHICS AND DISSEMINATION: The protocol has been approved by the Comité de Protection des Personnes Sud I (Ethics Review ID-RCB: 2019-A01829-48) for France and the Comité d'éthique hôpital-facultaire Saint Luc (N° B403201941338) for Belgium. It is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER: NCT04064489.

Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.

BACKGROUND: Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS: In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS: Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS: Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).

Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial.

OBJECTIVES: To determine whether hydroxychloroquine decreases the risk of adverse outcome in patients with mild to moderate coronavirus disease 2019 (COVID-19) at high risk of worsening. METHODS: We conducted a multicentre randomized double-blind placebo-controlled trial evaluating hydroxychloroquine in COVID-19 patients with at least one of the following risk factors for worsening: need for supplemental oxygen, age ≥75 years, age between 60 and 74 years and presence of at least one co-morbidity. Severely ill patients requiring oxygen therapy >3 L/min or intensive care were excluded. Eligible patients were randomized in a 1:1 ratio to receive either 800 mg hydroxychloroquine on day 0 followed by 400 mg per day for 8 days or a placebo. The primary end point was a composite of death or start of invasive mechanical ventilation within 14 days following randomization. Secondary end points included mortality and clinical evolution at days 14 and 28, and viral shedding at days 5 and 10. RESULTS: The trial was stopped after 250 patients were included because of a slowing down of the pandemic in France. The intention-to-treat population comprised 123 and 124 patients in the placebo and hydroxychloroquine groups, respectively. The median age was 77 years (interquartile range 58-86 years) and 151/250 (60.4%) patients required oxygen therapy. The primary end point occurred in 9/124 (7.3%) patients in the hydroxychloroquine group and 8/123 (6.5%) patients in the placebo group (relative risk 1.12; 95% CI 0.45-2.80). The rates of positive SARS-CoV-2 RT-PCR tests at days 5 and 10 were 72.8% (75/103) and 57.1% (52/91) in the hydroxychloroquine group, versus 73.0% (73/100) and 56.6% (47/83) in the placebo group, respectively. No difference was observed between the two groups in any of the other secondary end points. CONCLUSION: In this underpowered trial involving mainly older patients with mild to moderate COVID-19, patients treated with hydroxychloroquine did not experience better clinical or virological outcomes than those receiving the placebo. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04325893 (https://clinicaltrials.gov/ct2/show/NCT04325893).

Incidental findings on emergency CT scans: Predictive factors and medico-economic impact.

PURPOSE: The main objective was to evaluate types and predictive factors of incidental findings (IFs) on multidetector computed tomographies (MDCTs) performed for an emergency department (ED). The secondary aim was to analyze additional investigations, their benefits, side effects, costs and the final diagnoses. METHOD: One thousand consecutive patients over 18 years old who underwent an MDCT in the ED of our institution from January 2011 to November 2011 were retrospectively included, accounting for 300 head MDCTs and 700 other MDCTs. The following criteria were collected in patient electronic medical records: IFs (divided into low and high clinical significance), body areas covered, availability of a prior imaging, radiologist's experience and subspecialty, additional investigations, their outcomes and costs. RESULTS: Among the 1000 included patients, 232 had at least one IF and 122 had at least one IF of high clinical significance (IFCS). There were 340 IFs and 150 IFCSs. A significant association with the presence of at least one IF was noted for older patients, less-experienced radiologists, no subspecialty of the radiologist, the abdominopelvic area, and the absence of prior imaging. Eighteen IFs generated additional investigations in our institution, including five invasive samplings and three surgical operations, with two diagnoses of malignancy (a gastrointestinal stromal tumor and a Bosniak IV cystic renal lesion). One benign iatrogenic complication occurred. Total cost of these investigations was €41,247 (with an average of €2292 per IF investigated). CONCLUSION: IFs on emergency MDCTs were frequent, rarely severe, rarely iatrogenic and relatively expensive.

Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery.

BACKGROUND: The use of tranexamic acid reduces mortality due to postpartum hemorrhage. We investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery would decrease the incidence of postpartum hemorrhage. METHODS: In a multicenter, double-blind, randomized, controlled trial, we randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag. RESULTS: Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval [CI], 0.68 to 1.01; P=0.07). Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs. 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs. 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04). Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24). CONCLUSIONS: Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).

Perioperative Transcutaneous Tibial Nerve Stimulation to Reduce Postoperative Ileus After Colorectal Resection: A Pilot Study.

BACKGROUND: Postoperative ileus involves an inflammatory pathway characterized by an increase of inflammation mediators in the colon wall; this could probably be prevented by sacral nerve neuromodulation. The posterior tibial nerve can be stimulated electrically to mimic neuromodulation. OBJECTIVE: The aims of this study were to assess the efficacy of transcutaneous posterior tibial nerve stimulation in reducing the delay in GI motility recovery, to assess the safety of posterior tibial nerve stimulation in a perioperative setting, and to assess the efficacy of posterior tibial nerve stimulation in reducing the occurrence of postoperative ileus. DESIGN: This was a preliminary randomized controlled study. SETTINGS: This study was conducted in 1 academic hospital in France. PATIENTS: Forty patients undergoing an elective colectomy were included and randomly assigned into 2 groups, posterior tibial nerve stimulation or placebo, according to the side of colectomy and the surgical access size. INTERVENTION: Perioperative posterior tibial nerve stimulation or placebo was performed 3 times per day according to the randomly assigned group. MAIN OUTCOME MEASURES: Delay in GI motility recovery (passage of stool and tolerance of solid food) was measured. RESULTS: Of the 40 patients included, 34 were included in the final analysis, in which 2 patients in the placebo group were allocated the incorrect device. The 6 other patients were secondarily excluded because of protocol deviation. In the intention-to-treat analysis, the mean delay in GI motility recovery was 3.6 and 3.11 days (in the placebo and tibial nerve stimulation groups; p = 0.60). Occurrence of postoperative ileus was not significantly higher in the placebo group (35.3% vs 17.6%; p = 0.42). In the per-protocol analysis, we observed the same trends except for the occurrence of postoperative ileus, which was significantly higher in the placebo group (p = 0.045). Tolerance to posterior tibial nerve stimulation was good, and all of the patients completed the protocol. LIMITATIONS: The amplitude of stimulation is set according to patient sensation, so some patients could have been aware of their group. In addition there were some inherent limitations because of the preliminary nature of the study and several deviations from the protocol. CONCLUSIONS: Posterior tibial nerve stimulation was safe in a perioperative setting and had a potential effect on GI motility recovery. The results of this study will be useful for sample size calculations in a larger prospective randomized trial. See Video Abstract at http://links.lww.com/DCR/A708.

Polyphenols Have No Impact on Endothelial Function in Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial.

Background: Endothelial dysfunction, a pathophysiologic determinant of atherogenesis, has been found to occur in obstructive sleep apnea syndrome (OSA) and is improved by continuous positive airway pressure (CPAP). However, the efficacy of CPAP therapy is limited by variable adherence. Alternative treatment strategies are needed. The impact of polyphenols on endothelial function has never been evaluated in OSA. Objective: We evaluated the impact of 1-mo supplementation with grape juice polyphenols (GJPs) on the reactive hyperemia index (RHI), a validated measure of endothelial function in patients with severe OSA. Methods: Forty participants [75% men, median (IQR) age: 61 y (34, 64 y), BMI (in kg/m2): 30.6 (20.9, 33.7)] with severe OSA [median apnea-hypopnea index 43/h (33/h, 56/h)] were randomly assigned to receive GJPs (300 mg/d; n = 20) or placebo (n = 20) for 1 mo. The primary outcome was the change in RHI between baseline and after 1 mo of GJPs or placebo. Secondary outcome measures included changes in blood pressure (BP), heart rate (HR), and polysomnographic indexes. Results: No significant differences in RHI and BP outcomes were observed between the GJPs and placebo groups. A significant between-group difference was observed for HR changes [-1 bpm (-5, +5 bpm) in the GJPs group compared with +6 bpm (+3, +10 bpm) in the placebo group; P = 0.001]. A significant decrease in total sleep time was observed in the GJPs group compared with the placebo group [-10 min (-33, 6 min) compared with +15 min (-12, 40 min), respectively; P = 0.02], with no between-group differences in the distribution of sleep stages. Conclusions: In participants with severe OSA and no overt cardiovascular disease, 1-mo GJP supplementation had no effect on endothelial function. This trial was registered at clinicaltrials.gov as NCT01977924.

Cost-Minimisation Analysis of Erythropoiesis-Stimulating Agents in the Treatment of Anaemia in Dialysed Patients: A Pilot Study.

OBJECTIVE: This study aimed to assess the cost impact of administering erythropoiesis-stimulating agents once every 4 weeks instead of one to three times a week to treat anaemia in patients undergoing dialysis. METHODS: This was a monocentric retrospective study involving 27 patients who underwent haemodialysis between 2009 and 2013 in a university hospital in Angers, France. The study was a cost-minimisation analysis from the hospital perspective. Only direct medical costs were considered. RESULTS: This study demonstrated that therapeutic management of anaemia with methoxy polyethylene glycol-epoetin beta would save medical and nurse time (7 days and 15 days per year, respectively) and reduce costs by €59,960 a year for an active file of 40 patients undergoing haemodialysis, assuming a 100% occupancy rate in the above-mentioned hospital. CONCLUSION: This study indicated that treating anaemia by administering erythropoiesis-stimulating agents once every 4 weeks instead of one to three times a week in patients undergoing haemodialysis would be beneficial for the hospital.

Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial.

BACKGROUND: Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Estimates of its incidence in the literature vary widely, from 3 % to 15 % of deliveries. Uterotonics after birth are the only intervention that has been shown to be effective in preventing PPH. Tranexamic acid (TXA), an antifibrinolytic agent, has been investigated as a potentially useful complement to uterotonics for prevention because it has been proved to reduce blood loss in elective surgery, bleeding in trauma patients, and menstrual blood loss. Randomized controlled trials for PPH prevention after cesarean (n = 10) and vaginal (n = 2) deliveries show that women who received TXA had significantly less postpartum blood loss without any increase in their rate of severe adverse effects. However, the quality of these trials was poor and they were not designed to test the effect of TXA on the reduction of PPH incidence. Large, adequately powered, multicenter randomized controlled trials are required before the widespread use of TXA to prevent PPH can be recommended. METHODS AND DESIGN: A multicenter, double-blind, randomized controlled trial will be performed. It will involve 4000 women in labor for a planned vaginal singleton delivery, at a term ≥ 35 weeks. Treatment (either TXA 1 g or placebo) will be administered intravenously just after birth. Prophylactic oxytocin will be administered to all women. The primary outcome will be the incidence of PPH, defined by blood loss ≥500 mL, measured with a graduated collector bag. This study will have 80 % power to show a 30 % reduction in the incidence of PPH, from 10.0 % to 7.0 %. DISCUSSION: In addition to prophylactic uterotonic administration, a complementary component of the management of third stage of labor acting on the coagulation process may be useful in preventing PPH. TXA is a promising candidate drug, inexpensive, easy to administer, and simple to add to the routine management of deliveries in hospitals. This large, adequately powered, multicenter, randomized placebo-controlled trial seeks to determine if the risk-benefit ratio favors the routine use of TXA after delivery to prevent PPH. TRIAL REGISTRATION: ClinicalTrials.gov NCT02302456 (November 17, 2014).

Sedative premedication before surgery--A multicentre randomized study versus placebo.

OBJECTIVE: Anxiolytic premedication before non-ambulatory surgery in adult patients may have become of less importance in an era of better preoperative patient information. Moreover, an oral hypnotic given the night before surgery may be as efficient as an anxiolytic for relieving patient anxiety. These two strategies were compared for superiority to a placebo and to each other for non-inferiority. STUDY DESIGN: Double-blind, randomized, multicentre study versus placebo. Eight hospitals in France. June 2011 to February 2013. PATIENTS: Non-ambulatory consecutive surgical patients undergoing general surgery. METHODS AND INTERVENTIONS: Patients received either zopiclone 7.5mg the night before surgery (n=204), or alprazolam 0.5mg the morning of surgery (n=206) and controls received placebo (n=68). Demographic data, preoperative anxiety, fear of surgery and anaesthesia, and mood were assessed the day before surgery using a visual analogue scale, the Spielberger scale and the APAIS scale. In the operating room, anxiety and comfort were assessed in addition to physiological data. RESULTS: Preoperative data did not differ between groups. In the operating room, anxiety and comfort were moderate and did not differ significantly between groups on a 1-10 scale (median [25-75 percentile]): zopiclone: 2 [1-4] and 2.5 [1-5]; alprazolam: 2 [1,4] and 2 [1-5]; placebo: 3 [1-5] and 3 [1-5]. The patients who were more anxious preoperatively remained so in the operating room, irrespective of the treatment received (r=0.31, p<0.001). A placebo effect was observed in 38% of patients in the corresponding group. Patients receiving zopiclone reported a significantly better sleep the night before surgery compared to other groups (median: 2 vs. 1, p<0.001). CONCLUSIONS: Premedication in non-ambulatory surgery is no more effective than a placebo, owing to the very moderate level of anxiety experienced by patients.

[Creation and organization of an antivenomous serum bank in France]. / Création et organisation d'une banque des sérums antivenimeux en France.

For several years exotic snakes have been bred in France. In view of the increased risk of envenomation from some of these species, the Poison Centre in Angers has joined forces with several private licensed snake breeders to create an Anti-venom Serum Bank. The main objective of the new organization is to provide an effective means of dealing with bites and subsequent envenomation by exotic snakes by managing a stock of anti-venom serums in a hospital pharmacy, so that cases can be treated as quickly as possible. The hospital pharmacy has the authority to purchase and supply the anti-venom serums. The selection and purchase of the serums is done in conjunction with the French Ministry of Ecology, the French Drug Agency and specialist doctors. At the time of writing, the Antivenom Serum Bank has the capacity to treat about thirty different kinds of envenomation, compared to the 135 exotic venomous snake species officially registered. In the long term the Anti-venom Serum Bank will help eradicate the use of serums from unauthorized sources, evaluate the safety and efficacy of new serums and reduce transport times.