Time to source control and outcome in community-acquired intra-abdominal infections: The multicentre observational PERICOM study.

BACKGROUND: Optimal management of community-acquired intra-abdominal infections (IAI) requires timely surgical source control and adequate anti-infective treatment. OBJECTIVE: To describe the initial management of community-acquired IAI admitted to the emergency department and assess the association between the length of time to either diagnosis or therapeutic procedures and patient outcomes. DESIGN: A prospective, multicentre, observational study. SETTING: Thirteen teaching hospitals in France between April 2018 and February 2019. PATIENTS: Two hundred and five patients aged at least 18 years diagnosed with community-acquired IAI. MAIN OUTCOME MEASURES: The primary outcome was hospital length of stay. The secondary outcome was hospital mortality. RESULTS: Patients had a mean age of 56 (± 21) years and a median [interquartile] SAPS II of 26 [17 to 34]. Among the study cohort, 18% were postoperatively transferred to intensive care unit and 7% had died by day 28. Median [IQR] time to imaging, antibiotic therapy and surgery were 4 [2 to 6], 7.5 [4 to 12.5] and 9 [5.5 to 17] hours, respectively. The length of time to surgical source control [0.99, 95% confidence interval (CI), 0.98 to 0.99], SOFA greater than 2 [0.36 (95% CI, 0.26 to 0.651)], age greater than 60 years [0.65 (95% CI, 0.45 to 0.94)], generalized peritonitis [0.7 (95% CI, 0.56 to 0.89)] and laparotomy surgery [0.657 (95% CI, 0.42 to 0.78)] were associated with longer hospital length of stay. The duration of time to surgical source control [1.02 (95% CI, 1.01 to 1.04)], generalized peritonitis [2.41 (95% CI, 1.27 to 4.61)], and SOFA score greater than 2 [6.14 (95% CI, 1.40 to 26.88)] were identified as independent risk factors for 28-day mortality. CONCLUSION: This multicentre observational study revealed that the time to surgical source control, patient severity and generalized peritonitis were identified as independent risk factors for increased hospital LOS and mortality in community-acquired IAI. Organisational strategies to reduce the time to surgical management of intra-abdominal infections should be further evaluated. STUDY REGISTRATION: ClinicalTrials.gov on 1 April 2018, NCT03544203.

Gunshot and stab wounds in France: descriptive study from a national trauma registry.

PURPOSE: Severe trauma is a major problem worldwide. In France, blunt trauma (BT) is predominant and few studies are available on penetrating trauma (PT). The purpose of this study was to perform a descriptive analysis of severe gunshot (GSW) and stab wounds (SW) in patients who were treated in French trauma centers. METHODS: Retrospective study on prospectively collected data in a national trauma registry. All adult (> 15 years) trauma patients primarily admitted in 1 of the 17 trauma centers members of the Traumabase between January 2015 to December 2018 were included. Data from patients who had a PT were compared with those who had suffered a BT over the same period. Due to the known differences between GSW and SW, sub-group analyses on data from GSW, SW and BT were also performed. RESULTS: 8128 patients were included. Twelve percent of the study group had a PT. The main mechanism of PT was SW (68.1%). Five hundred and eighty patients with PT (59.4%) required surgery within the first 24 h. Severe hemorrhage was more frequent in penetrating traumas (11.2% vs. 7.8% p < 0.001). Hospital mortality following PT was 8.9% vs 11% for blunt trauma (p = 0.047). Among PT the mortality after GSW was ten times higher than after SW (23.8% vs 2%). CONCLUSION: This work is the largest study to date that has specifically focused on GSW and SW in France, and will help improving knowledge in managing such patients in our country.

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.

Clinico-Biological Features and Clonal Hematopoiesis in Patients with Severe COVID-19.

Advanced age or preexisting comorbidities have been characterized as risk factors for severe coronavirus disease 2019 (COVID-19) cases requiring hospitalization and intensive care. In recent years, clonal hematopoiesis (CH) of indeterminate potential (CHIP) has emerged as a risk factor for chronic inflammatory background and subsequent aging-associated diseases. The purpose of this study was to identify biological factors (particularly leukocyte subtypes and inflammatory markers) associated with a risk of clinical deterioration (i.e., orotracheal intubation (OTI)) and to determine whether CH was likely to influence clinical and biological behavior in patients with severe COVID-19 requiring hospitalization. Here, we describe clinical and biological features, including the screening of CHIP mutants in a well-annotated cohort of 122 hospitalized patients with a laboratory-confirmed diagnosis of COVID-19 (55% requiring OTI). We showed that elevated white blood cell counts, especially neutrophils and high C-reactive protein (CRP) levels at admission, were associated with an increased requirement of OTI. We noticed a high prevalence of CH (25%, 38%, 56%, and 82% of patients aged <60 years, 60-70 years, 70-80 years, and >80 years) compared to a retrospective cohort of patients free of hematological malignancy explored with the same pipelines (10%, 21%, 37%, and 44%). However, the existence of CH did not significantly impact clinical outcome, including OTI or death, and did not correlate with other laboratory findings.

Effect of fibrinogen concentrate administration on early mortality in traumatic hemorrhagic shock: A propensity score analysis.

BACKGROUND: Fibrinogen concentrate is widely used in traumatic hemorrhagic shock despite weak evidence in the literature. The aim of the study was to evaluate the effect of fibrinogen concentrate administration within the first 6 hours on 24-hour all-cause mortality in traumatic hemorrhagic shock using a causal inference approach. METHODS: Observational study from a French multicenter prospective trauma registry was performed. Hemorrhagic shock was defined as transfusion of four or more red blood cell units within the first 6 hours after admission. The confounding variables for the outcome (24-hour all-cause mortality) and treatment allocation (fibrinogen concentrate administration within the first 6 hours) were chosen by a Delphi method. The propensity score was specified with a data-adaptive algorithm and a doubly-robust approach with inverse proportionality of treatment weighting allowed to compute the average treatment effect. Sensitivity analyses were performed. RESULTS: Of 14,336 patients in the registry during the study period, 1,027 in hemorrhagic shock were analyzed (758 receiving fibrinogen concentrate within 6 hours and 269 not receiving fibrinogen concentrate). The average treatment effect, expressed as a risk difference, was -0.031 (95% confidence interval, -0.084 to 0.021). All sensitivity analysis confirmed the results. CONCLUSIONS: Fibrinogen concentrate administration within the first 6 hours of a traumatic hemorrhagic shock did not decrease 24-hour all-cause mortality. LEVEL OF EVIDENCE: Prognostic, level III.

Early management of severe abdominal trauma.

OBJECTIVE: To develop French guidelines on the management of patients with severe abdominal trauma. DESIGN: A consensus committee of 20 experts from the French Society of Anaesthesiology and Critical Care Medicine (Société française d'anesthésie et de réanimation, SFAR), the French Society of Emergency Medicine (Société française de médecine d'urgence, SFMU), the French Society of Urology (Société française d'urologie, SFU) and from the French Association of Surgery (Association française de chirurgie, AFC), the Val-de-Grâce School (École du Val-De-Grâce, EVG) and the Federation for Interventional Radiology (Fédération de radiologie interventionnelle, FRI-SFR) was convened. Declaration of all conflicts of interest (COI) policy by all participants was mandatory throughout the development of the guidelines. The entire guideline process was conducted independently of any industry funding. The authors were advised to follow the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system for assessment of the available level of evidence with particular emphasis to avoid formulating strong recommendations in the absence of high level. Some recommendations were left ungraded. METHODS: The guidelines are divided in diagnostic and, therapeutic strategy and early surveillance. All questions were formulated according to Population, Intervention, Comparison, and Outcomes (PICO) format. The panel focused on three questions for diagnostic strategy: (1) What is the diagnostic performance of clinical signs to suggest abdominal injury in trauma patients? (2) Suspecting abdominal trauma, what is the diagnostic performance of prehospital FAST (Focused Abdominal Sonography for Trauma) to rule in abdominal injury and guide the prehospital triage of the patient? and (3) When suspecting abdominal trauma, does carrying out a contrast enhanced thoraco-abdominal CT scan allow identification of abdominal injuries and reduction of mortality? Four questions dealt with therapeutic strategy: (1) After severe abdominal trauma, does immediate laparotomy reduce morbidity and mortality? (2) Does a "damage control surgery" strategy decrease morbidity and mortality in patients with a severe abdominal trauma? (3) Does a laparoscopic approach in patients with abdominal trauma decrease mortality or morbidity? and (4) Does non-operative management of patients with abdominal trauma without bleeding reduce mortality and morbidity? Finally, one question was formulated regarding the early monitoring of these patients: In case of severe abdominal trauma, which kind of initial monitoring does allow to reduce the morbi-mortality? The analysis of the literature and the recommendations were conducted following the GRADE® methodology. RESULTS: The SFAR/SFMU Guideline panel provided 15 statements on early management of severe abdominal trauma. After three rounds of discussion and various amendments, a strong agreement was reached for 100% of recommendations. Of these recommendations, five have a high level of evidence (Grade 1±), six have a low level of evidence (Grade 2±) and four are expert judgments. Finally, no recommendation was provided for one question. CONCLUSIONS: Substantial agreement exists among experts regarding many strong recommendations for the best early management of severe abdominal trauma.

Association of Prehospital Time to In-Hospital Trauma Mortality in a Physician-Staffed Emergency Medicine System.

Importance: The association between total prehospital time and mortality in physician-staffed trauma systems remains uncertain. Objective: To describe the association of total prehospital time and in-hospital mortality in prehospital, physician-staffed trauma systems in France, with the hypothesis that total prehospital time is associated with increased mortality. Design, Setting, and Participants: This cohort study was conducted from January 2009 to December 2016. Data for this study were derived from 2 distinct regional trauma registries in France (1 urban and 1 rural) that both have a physician-staffed emergency medical service. Consecutive adult trauma patients admitted to either of the regional trauma referral centers during the study period were included. Data analysis took place from March 2018 to September 2018. Main Outcomes and Measures: The association between death and prehospital time was assessed with a multivariable model adjusted with confounders. Total prehospital time was the primary exposure variable, recorded as the time from the arrival of the physician-led prehospital care team on scene to the arrival at the hospital. The main outcome of interest was all-cause in-hospital mortality. Results: A total of 10 216 patients were included (mean [SD] age, 41 [18] years; 7937 men [78.3%]) affected by predominantly nonpenetrating injuries (9265 [91.5%]), with a mean (SD) Injury Severity Score of 17 (14) points. Of the patients, 6737 (66.5%) had at least 1 body region with an Abbreviated Injury Scale score of 3 or more. A total of 1259 patients (12.4%) presented in shock (with systolic pressure <90 mm Hg) and 2724 (26.9%) with severe head injury (Abbreviated Injury Scale score ≥3 points). On unadjusted analysis, increasing prehospital times (in 30-minute categories) were associated with a markedly and constant increase in the risk of in-hospital death. The odds of death increased by 9% for each 10-minute increase in prehospital time (odds ratio, 1.09 [95% CI, 1.07-1.11]) and after adjustment by 4% (odds ratio, 1.04 [95% CI, 1.01-1.07]). Conclusions and Relevance: In this study, an increase in total prehospital time was associated with increasing in-hospital all-cause mortality in trauma patients at a physician-staffed emergency medical system, after adjustment for case complexity. Prehospital time is a management objective in analogy to physiological targets. These findings plead for a further streamlining of prehospital trauma care and the need to define the optimal intervention-to-time ratio.

Position of the French Working Group on Perioperative Haemostasis (GIHP) on viscoelastic tests: What role for which indication in bleeding situations?

PURPOSE: Viscoelastic tests (VETs), thromboelastography (TEG®) and thromboelastometry (ROTEM®) are global tests of coagulation performed on whole blood. They evaluate the mechanical strength of a clot as it builds and develops after coagulation itself. The time required to obtain haemostasis results remains a major problem for clinicians dealing with bleeding, although some teams have developed a rapid laboratory response strategy. Indeed, the value of rapid point-of-care diagnostic devices such as VETs has increased over the years. However, VETs are not standardised and there are few recommendations from the learned societies regarding their use. In 2014, the recommendations of the International Society of Thrombosis and Haemostasis (ISTH) only concerned haemophilia. The French Working Group on Perioperative haemostasis (GIHP) therefore proposes to summarise knowledge on the clinical use of these techniques in the setting of emergency and perioperative medicine. METHODS: A review of the literature. PRINCIPAL FINDINGS: The role of the VETs seems established in the management of severe trauma and in cardiac surgery, both adult and paediatric. In other situations, their role remains to be defined: hepatic transplantation, postpartum haemorrhage, and non-cardiac surgery. They must be part of the global management of haemostasis based on algorithms defined in each centre and for each population of patients. Their position at the bedside or in the laboratory is a matter of discussion between clinicians and biologists. CONCLUSION: VETs must be included in algorithms. In consultation with the biology laboratory, these devices should be situated according to the way each centre functions.

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.

Early management of severe pelvic injury (first 24 hours).

OBJECTIVE: Pelvic fractures represent 5% of all traumatic fractures and 30% are isolated pelvic fractures. Pelvic fractures are found in 10 to 20% of severe trauma patients and their presence is highly correlated to increasing trauma severity scores. The high mortality of pelvic trauma, about 8 to 15%, is related to actively bleeding pelvic injuries and/or associated injuries to the head, abdomen or chest. Regardless of the severity of pelvic trauma, diagnosis and treatment must proceed according to a strategy that does not delay the management of the most severely injured patients. To date, in France, there are no guidelines issued by healthcare authorities or professional societies that address this subject. DESIGN: A consensus committee of 22 experts from the French Society of Anaesthesia and Intensive Care Medicine (Société Française d'Anesthésie et de Réanimation; SFAR) and the French Society of Emergency Medicine (Société Française de Médecine d'Urgence; SFMU) in collaboration with the French Society of Radiology (Société Française de Radiologie; SFR), French Defence Health Service (Service de Santé des Armées; SSA), French Society of Urology (Association Française d'Urologie; AFU), the French Society of Orthopaedic and Trauma Surgery (Société Française de Chirurgie Orthopédique et Traumatologique; SOCFCOT), and the French Society of Digestive Surgery (Société Française de Chirurgie digestive; SFCD) was convened. A formal conflict-of-interest (COI) policy was developed at the onset of the process and enforced throughout. The entire guidelines process was conducted independently from any industry funding. The authors were advised to follow the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to guide assessment of quality of evidence. The potential drawbacks of making strong recommendations in the presence of low-quality evidence were emphasised. METHODS: Population, intervention, comparison, and outcomes (PICO) questions were reviewed and updated as needed, and evidence profiles were generated. The analysis of the literature and the recommendations were then conducted according to the GRADE® methodology. RESULTS: The SFAR Guideline panel provided 22 statements on prehospital and hospital management of the unstable patient with pelvic fracture. After three rounds of discussion and various amendments, a strong agreement was reached for 100% of recommendations. Of these recommendations, 11 have a high level of evidence (Grade 1 ± ), 11 have a low level of evidence (Grade 2 ± ). CONCLUSIONS: Substantial agreement exists among experts regarding many strong recommendations for management of the unstable patient with pelvic fracture.