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.

Prothrombin Time ratio can predict mortality in severe pediatric trauma: Study in a French trauma center level 1.

BACKGROUND: Injury results in more deaths in children than all other causes combined, but there is little data regarding the association of early coagulopathy on outcomes in pediatric patients with traumatic injuries. The aim of this study was to determine the optimal cut-off value for the Prothrombin Time ratio (PTr) and to show the diagnostic characteristics of the PTr to predict mortality. METHODS: We retrospectively included during 4 years all patients less than 16 years old referred to our trauma center for traumatic injury with ISS ≥9. RESULTS: A total of 272 children were included. Mean age was 9.4 ± 4.8 years and median ISS was 17 [interquartile range, 12 to 26]. Day 28 mortality was 6.7%. The optimal cut-off value in our population for predicting day 28 mortality was 1.24. Using this value, the sensitivity of PTr was 84%, specificity was 82%, positive likelihood ratio was 4.7, and negative likelihood ratio was 0.19. Early mortality (i.e., mortality at 24 h) was also well-predicted (1.0% versus 16.4%, p < .0001), as the need for massive transfuion. Similarly, patients with PTr ≥1.24 at admission presented with a higher rate of severe thoracic and abdominal trauma, higher ISS, higher likelihood of admission to an intensive care unit, longer hospitalization, and higher rate of significant procedure (e.g., surgery or embolization). CONCLUSIONS: Trauma-induced coagulopathy defined only by a PTr ≥1.24 could be used as a severity predictive marker and as a sensitive, specific, quick, and easy to use tool for admission triage of pediatric patients.

Strategic proposal for a national trauma system in France.

In this road map for trauma in France, we focus on the main challenges for system implementation, surgical and radiology training and upon innovative training techniques. Regarding system organisation: procedures for triage, designation and certification of trauma centres are mandatory to implement trauma networks on a national scale. Data collection with registries must be created, with a core dataset defined and applied through all registries. Regarding surgical and radiology training, diagnostic-imaging processes should be standardised and the role of the interventional radiologist within the trauma team and the trauma network should be clearly defined. Education in surgery for trauma is crucial and recent changes in medical training in France will promote trauma surgery as a specific sub-specialty. Innovative training techniques should be implemented and be based on common objectives, scenarios and evaluation, so as to improve individual and team performances. The group formulated 14 proposals that should help to structure and improve major trauma management in France over the next 10 years.