Quality of life of patients with hip fracture was better during the COVID-19 period than before, an ancillary study from the HiFIT multicenter study.

Background: The COVID-19 pandemic had a global impact on people life, notably because of lockdown periods. This could particularly affected patients suffering from hip fracture, who could have been more isolated during these periods. We aim at evaluating the impact of the COVID-19 period (including lockdown periods) on quality of life (QOL) in older adult patients 90 days after a surgery for a hip fracture. Subject and methods: Ancillary study of the prospective randomized controlled HiFIT study. We compared the QOL measured at 90 days after a hip fracture surgery using the EuroQOL-5 dimensions 3 levels (EQ-5D), the Perceived Quality of life (PQOL) and the Instrumental Activities of Daily Living (IADL) in patients included in the Hifit study before and during the COVID-19 pandemic. Results: The characteristics of the 161 patients included before and of the 213 included during the COVID period (including 122 (57%) during COVID with containment periods and 91 (43%) during COVID without containment periods) were similar (mean age 84 ± 10 years; 282 (75%) women). The majority (81%) of the patients alive at 90 days had returned to their previous place of residence in both periods. During the COVID period, EQ-5D showed better patient pain/discomfort and anxiety/depression levels. The PQOL happiness was not different, with around 81% of the patient being "happy" or "very happy" during the two periods and the IADL was also similar during the two periods. In the multivariate analysis odd ratios of having poorer outcomes were increased before COVID for pain/discomfort (OR 2.38, 95%CI [1.41-4.15], p = 0.001), anxiety (OR 1.89 [1.12-3.21], p = 0.017) and mobility (1.69 [1.02-2.86], p = 0.044). Conclusion: Patient's quality of life measured using different scales was not altered during the COVID period compared to before COVID, 90 days after a hip fracture. Surprisingly, the Pain/Discomfort and Anxiety dimensions of the EQ-5D questionnaires were even better during the COVID period.Clinical trial registration:https://clinicaltrials.gov/ (NCT02972294).

Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial.

BACKGROUND: Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery. METHODS: In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants. FINDINGS: Of 413 patients (51-104 years old, median [IQR] 86 [78-91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27-0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50-1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54-1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups. INTERPRETATION: In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5-13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it. FUNDING: French Ministry of Health, HiFIT trial.

Study protocol for a multicentre, 2×2 factorial, randomised, controlled trial evaluating the interest of intravenous iron and tranexamic acid to reduce blood transfusion in hip fracture patients (the HiFIT study).

INTRODUCTION: Blood transfusion and anaemia are frequent and are associated with poor outcomes in patients with hip fracture (HF). We hypothesised that preoperative intravenous iron and tranexamic acid (TXA) may reduce the transfusion rate in these patients. METHODS AND ANALYSIS: The HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA (intravenously at inclusion and topically during surgery) versus placebo on transfusion rate during hospitalisation, in patients undergoing emergency surgery for HF and having a preoperative haemoglobin between 95 and 130 g/L. 780 patients are expected. The primary endpoint is the proportion of patients receiving an allogenic blood transfusion of packed red blood cells from the day of surgery until hospital discharge (or until D30 if patient is still hospitalised). Enrolment started on March 2017 in 11 French hospitals. The study was stopped between July 2017 and August 2018 (because of investigation of serious AEs with IIM in Spain) and slowed down since March 2020 (COVID-19 crisis). The expected date of final follow-up is May 2022. Analyses of the intent-to-treat and per-protocol populations are planned. ETHICS AND DISSEMINATION: The HiFIT trial protocol has been approved by the Ethics Committee of Comité de Protection des Personnes Ouest II and the French authorities (ANSM). It will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The HiFIT trial will be the largest study evaluating iron and TXA in patients with HF. TRIAL REGISTRATION NUMBER: clinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.

Preoperative Epoetin-α with Intravenous or Oral Iron for Major Orthopedic Surgery: A Randomized Controlled Trial.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Preoperative administration of epoetin-α with iron is commonly used in anemic patients undergoing major orthopedic surgery, but the optimal route of iron intake is controversial. The aim of this study was to compare the clinical effects of erythropoietin in combination with oral or intravenous iron supplementation. METHODS: This study was a prospective, randomized, single-blinded, parallel arm trial. Patients scheduled for elective hip or knee arthroplasty with hemoglobin 10 to 13 g/dl received preoperative injections of erythropoietin with oral ferrous sulfate or intravenous ferric carboxymaltose. The primary endpoint was the hemoglobin value the day before surgery. RESULTS: One hundred patients were included in the analysis. The day before surgery, hemoglobin, increase in hemoglobin, and serum ferritin level were higher in the intravenous group. For the intravenous and oral groups, respectively, hemoglobin was as follows: median, 14.9 g/dl (interquartile range, 14.1 to 15.6) versus 13.9 g/dl (interquartile range, 13.2 to 15.1), group difference, 0.65 g/dl (95% CI, 0.1 to 1.2; P = 0.017); increase in hemoglobin: 2.6 g/dl (interquartile range, 2.1 to 3.2) versus 1.9 g/dl (interquartile range, 1.4 to 2.5), group difference, 0.7 g/dl (95% CI, 0.3 to 1.1; P < 0.001); serum ferritin: 325 µg/l (interquartile range, 217 to 476) versus 64.5 µg/l (interquartile range, 44 to 107), group difference, 257 µg/l (95% CI, 199 to 315; P < 0.001). The percentage of patients with nausea, diarrhea, or constipation was higher in the oral group, 52% versus 2%; group difference, 50% (95% CI, 35 to 64%; P < 0.0001). CONCLUSIONS: After preoperative administration of erythropoietin, body iron stores and stimulation of the erythropoiesis were greater with intravenous ferric carboxymaltose than with oral ferrous sulfate supplementation.

Postoperative fasting after general anaesthesia: A survey of French anaesthesiology practices.

BACKGROUND: Preoperative fasting is well codified worldwide. In contrast, the literature on the postoperative fasting (POF) is scarce, leading to potentially wide discrepancies among anaesthesiology practices. This survey assessed French POF practices. METHODS: From March 2013 to January 2014, a survey was conducted among anaesthesiologists, members of the French Society of Anaesthesiology and Intensive Care Medicine (SFAR). The POF durations of either fluid or solid food intake was assessed according to airway management procedures (endotracheal intubation [EI] or laryngeal mask [LMA]) and age of the patients (adult or paediatric). RESULTS: Seven hundred and fifty-four surveys were returned (67% from public hospital practitioners and 33% from private hospital and clinic practitioners). The majority of anaesthesiologists allowed fluid intake 2h after EI and immediately after discharge from PACU following LMA. For solid food resumption, it was 2h for children and 4h for adults after EI and 2h for both children and adults after LMA. Regardless of the airway management procedures, fasting was permitted immediately after PACU discharge more frequently in public than in private hospitals (36% vs. 33%, P<0.05). Four hours after the end of surgery, the rate was significantly higher in private than in public hospitals (93% vs. 89 %, P<0.001). CONCLUSIONS: All in all, POF lasted less than 4hours after surgery regardless of airway management. They were shorter with regard to fluid intake, paediatric patients and LMA in comparison with solid food, adult patients and EI respectively.

Pleth variability index predicts fluid responsiveness in critically ill patients.

OBJECTIVE: To investigate whether the pleth variability index, a noninvasive and continuous tool, can predict fluid responsiveness in mechanically ventilated patients with circulatory insufficiency. DESIGN: Prospective study. SETTING: Surgical intensive care unit of a university hospital. PATIENTS: Forty mechanically ventilated patients with circulatory insufficiency in whom volume expansion was planned by attending physician. Exclusion criteria included spontaneous respiratory activity, cardiac arrhythmia, known intracardiac shunt, severe hypoxemia (Pao2/Fio2 <100 mm Hg), contraindication for passive leg raising, left ventricular ejection fraction of <50%, and hemodynamic instability during the procedure. INTERVENTIONS: Fluid challenge with 500 mL of 130/0.4 hydroxyethyl-starch if respiratory variations in arterial pulse pressure were ≥ 13% or with passive leg raising if variations in arterial pulse pressure were <13%. MEASUREMENTS AND MAIN RESULTS: Pleth variability index, variations in arterial pulse pressure, and cardiac output estimated by echocardiography were recorded before and after fluid challenge. Fluid responsiveness was defined as an increase in cardiac output of ≥ 15%. Twenty-one patients were responders and 19 were nonresponders. Mean ± sd pleth variability index (28% ± 13% vs. 11% ± 4%) and arterial pulse pressure variation (22% ± 11% vs. 5% ± 2%) values at baseline were significantly higher in responders than in nonresponders. The pleth variability index threshold value of 17% allowed discrimination between responders and nonresponders with a sensitivity of 95% (95% confidence interval, 74% to 100%) and a specificity of 91% (95% confidence interval, 70% to 99%). The pleth variability index at baseline correlated (r = .72, p < .0001) with the percentage change in cardiac output induced by fluid challenge, suggesting that a higher pleth variability index at baseline will correlate with a higher percentage change in cardiac output after volume expansion. CONCLUSIONS: The pleth variability index can predict fluid responsiveness noninvasively in intensive care unit patients under mechanical ventilation.