7 research outputs found

    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

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    BackgroundThe 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 methodsAncillary 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.ResultsThe 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).ConclusionPatient’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)

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

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    International audienceWHAT 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 \textless 0.001); serum ferritin: 325 \textmug/l (interquartile range, 217 to 476) versus 64.5 \textmug/l (interquartile range, 44 to 107), group difference, 257 \textmug/l (95% CI, 199 to 315; P \textless 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 \textless 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

    Study protocol for a multicentre, 2Ă—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)

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    International audienceIntroduction 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
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