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BACKGROUND: Trauma hemorrhage induces a coagulopathy with a high associated mortality rate. The Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy (ITACTIC) randomized trial tested two goal-directed treatment algorithms for coagulation management, one guided by conventional coagulation tests and one by viscoelastic hemostatic assays (viscoelastic). The lack of a difference in 28-day mortality led us to hypothesize that coagulopathic patients received insufficient treatment to correct coagulopathy. METHODS: During ITACTIC, two sites were co-enrolling patients into an ongoing prospective observational study, which included serial blood sampling at the same intervals as in ITACTIC. The subgroup in both studies had conventional and viscoelastic test results for each patient available for analysis. A goal-directed treatment was defined as one triggered by an ITACTIC algorithm. Coagulopathy was defined as ROTEM EXTEM A5 <40mm. The primary outcome was correction of coagulopathy by the 12th unit of red blood cell transfusion during resuscitation. RESULTS: Full viscoelastic and conventional coagulation test results were available for 133 patients. 71% were coagulopathic on admission, and 16% developed a coagulopathy during resuscitation. ITACTIC VHA group patients were more likely to receive goal-directed treatment than the standard group (76% vs 47%, OR 3.73, 95%CI:1.64-8.49, p=0.002). However, only 54% of patients received goal-directed treatment, and only 20% corrected their coagulopathy (vs 0% with empiric treatment alone, not significant). Median time to first goal-directed treatment was 68(53-88) minutes for viscoelastic and 110(77-123) minutes for standard, p=0.005. CONCLUSION: In ITACTIC, many bleeding trauma patients did not receive an indicated goal-direct treatment. Interventions arrived late during resuscitation and were only partially effective at correcting coagulopathy.
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BACKGROUND: Approximately 30,000 people are affected by severe injuries in Germany each year. Continuous progress in prehospital and hospital care has significantly reduced the mortality of polytrauma patients. With increasing survival rates, the functional outcome, health-related quality (hrQoL) of life and ability to work are now gaining importance. Aim of the study is, the presentation of the response behavior of seriously injured patients on the one hand and the examination of the factors influencing the quality of life and ability to work 12 months after major trauma on the other hand. Building on these initial results, a standard outcome tool shall be integrated in the established TraumaRegister DGU® in the future. METHODS: In 2018, patients [Injury Severity Score (ISS) ≥ 16; age:18-75 years] underwent multicenter one-year posttraumatic follow-up in six study hospitals. In addition to assessing hrQoL by using the Short-Form Health Survey (SF-12), five additional questions (treatment satisfaction; ability to work; trauma-related medical treatment; relevant physical disability, hrQoL as compared with the prior to injury status) were applied. RESULTS: Of the 1,162 patients contacted, 594 responded and were included in the analysis. The post-injury hrQoL does not show statistically significant differences between the sexes. Regarding age, however, the younger the patient at injury, the better the SF-12 physical sum score. Furthermore, the physically perceived quality of life decreases statistically significantly in relation to the severity of the trauma as measured by the ISS, whereas the mentally perceived quality of life shows no differences in terms of injury severity. A large proportion of severely injured patients were very satisfied (42.2%) or satisfied (39.9%) with the treatment outcome. It should be emphasized that patients with a high injury severity (ISS > 50) were on average more often very satisfied with the treatment outcome (46.7%). A total of 429 patients provided information on their ability to work 12 months post-injury. Here, 194 (45.2%) patients had a full employment, and 58 (13.5%) patients were had a restricted employment. CONCLUSION: The present results show the importance of a structured assessment of the postinjury hrQoL and the ability to work after polytrauma. Further studies on the detection of influenceable risk factors on hrQoL and ability to work in the intersectoral course of treatment should follow to enable the best possible outcome of polytrauma survivors.
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Calidad de Vida , Sistema de Registros , Humanos , Calidad de Vida/psicología , Alemania , Masculino , Femenino , Persona de Mediana Edad , Proyectos Piloto , Adulto , Anciano , Adolescente , Adulto Joven , Puntaje de Gravedad del Traumatismo , Encuestas y Cuestionarios , Traumatismo Múltiple/psicología , Traumatismo Múltiple/terapia , Heridas y Lesiones/psicología , Heridas y Lesiones/terapiaRESUMEN
BACKGROUND: The prevalence of anticoagulation treatment is increasing as an aging global population faces a high burden of cardiovascular comorbidities. Direct oral anticoagulants, including factor Xa inhibitors (FXai), are replacing vitamin K antagonists as the most commonly prescribed treatment for reducing risk of thrombotic events. While the risk of FXai-associated spontaneous bleeds is established, less is understood about their management and the effect of treatment on clinical and patient-reported outcomes. The primary objectives of the REVERXaL study are to describe patient characteristics, health care interventions during the acute-care phase, in-hospital outcomes, and associations between timing of reversal/replacement agent administration and in-hospital outcomes. Secondary/exploratory objectives focus on clinical assessments and patient-reported outcome measures (PROMs) at 30 and 90 days. METHODS: REVERXaL is a multinational, observational study of hospitalized patients with FXai-associated major bleeds in Germany, Japan, the United Kingdom, and the United States. The study includes 2 cohorts of approximately 2000 patients each. Cohort A is a historic cohort for whom medical chart data will be collected from hospitalization to discharge for patients admitted for major bleeds during FXai use within 2 years prior to enrollment of Cohort B. Cohort B will prospectively enroll patients administered any reversal/replacement agent during hospitalization to manage FXai-associated major bleeds and will include the collection of clinical outcomes and PROMs data over 3 months. CONCLUSIONS: REVERXaL will generate insights on patient characteristics, treatment approaches, and associated outcomes in patients hospitalized with FXai-associated major bleeds. These data may inform clinical practice and streamline treatment pathways in this population. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; unique identifier: NCT06147830.
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Inhibidores del Factor Xa , Hemorragia , Humanos , Inhibidores del Factor Xa/uso terapéutico , Inhibidores del Factor Xa/efectos adversos , Hemorragia/inducido químicamente , Femenino , Masculino , Anciano , Persona de Mediana Edad , Estudios de CohortesRESUMEN
BACKGROUND: Inadequate clinical experience still causes uncertainty in the acute diagnostic evaluation and treatment of polytrauma in children (with or without coagulopathy). This review deals with the main aspects of the acute care of severely injured children in the light of current guidelines and other relevant literature, in particular airway control, volume and coagulation management, acute diagnostic imaging, and blood coagulation studies in the shock room. METHODS: This review is based on literature retrieved by a selective search in PubMed, Medline (OVIDSP), the Cochrane Central Register of Controlled Trials, and Epistemonikos covering the period January 2001 to August 2023. Review articles and the updated S2k clinical practice guideline on polytrauma management in childhood were considered. RESULTS: Most accidents in childhood occur at home and in the child's free time, with varying mechanisms and patterns of injury depending on age. The outcome of treatment depends largely on the presence or absence or traumatic brain injury, which affects 66% of children with polytrauma and is thus the most common type of injury in this group, and of hemorrhagic shock with or without coagulopathy. Acute care follows the ABCDE algorithms with attention to special features in children, including age-specific reference values. According to a registry study, coagulopathy and hypovolemic shock are associated with 22% and 17% mortality, respec - tively. Treatment in a pediatric trauma reference center of the trauma network is recommended. Computed tomography (CT) should be carried out in children in accordance with defined criteria (PECARN), as a team decision and with the use of age-specific low-dose CT protocols. In children as in adults, viscoelasticity-based point-of-care tests enable the prompt diagnosis of relevant coagulopathies and their treatment in consideration of age-specific target values. The administration of tranexamic acid remains controversial. CONCLUSION: 4% of polytrauma patients are children. Because children differ from adults both anatomically and physiologically, the diagnostic evaluation and management of polytrauma in children presents a special challenge. The evidence base for pediatric polytrauma management is still inadequate; current recommendations are based on consensus, in consideration of the special features of children compared to adults.
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Traumatismo Múltiple , Humanos , Traumatismo Múltiple/terapia , Traumatismo Múltiple/diagnóstico por imagen , Traumatismo Múltiple/diagnóstico , Niño , Preescolar , Adolescente , Lactante , Trastornos de la Coagulación Sanguínea/terapia , Trastornos de la Coagulación Sanguínea/diagnóstico , Trastornos de la Coagulación Sanguínea/etiologíaRESUMEN
PURPOSE OF REVIEW: Noncompressible torso hemorrhage (NCTH) is now considered as the major cause of preventable death after both severe military and civilian trauma. Around 20% of all trauma patients still die from uncontrolled exsanguination along with rapidly evolving hemostatic failure. This review highlights the most recent advances in the field and provides an outline for future research directions. RECENT FINDINGS: The updated definition of NCTH includes a combination of high-grade anatomical torso injury, hemodynamic instability, urgent need for hemorrhage control and aggressive hemostatic resuscitation. Therapeutic concepts consider the following three aspects: control the bleeding source (close the tap), resuscitate to maintain organ perfusion and restore hemostasis (fill the tank), and increase the body's resistance against ischemia (upgrade the armor). SUMMARY: The concepts for the early management of NCTH have substantially evolved over the last decade. The development of new devices and techniques combined with early intervention of hemostatic failure have contributed to more successful resuscitations. Future research needs to refine and validate their potential clinical application.
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Hemorragia , Resucitación , Humanos , Resucitación/métodos , Hemorragia/terapia , Torso , Técnicas Hemostáticas , Exsanguinación/terapiaRESUMEN
Considerable political, structural, environmental and epidemiological change will affect high socioeconomic index (SDI) countries over the next 25 years. These changes will impact healthcare provision and consequently trauma systems. This review attempts to anticipate the potential impact on trauma systems and how they could adapt to meet the changing priorities. The first section describes possible epidemiological trajectories. A second section exposes existing governance and funding challenges, how these can be met, and the need to incorporate data and information science into a learning and adaptive trauma system. The last section suggests an international harmonization of trauma education to improve care standards, optimize immediate and long-term patient needs and enhance disaster preparedness and crisis resilience. By demonstrating their capacity for adaptation, trauma systems can play a leading role in the transformation of care systems to tackle future health challenges.
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Planificación en Desastres , Humanos , Atención a la Salud , Factores SocioeconómicosRESUMEN
Uncontrolled hemorrhage and trauma-induced coagulopathy (TIC) remain the two predominante causes of preventable death after trauma. Early control of bleeding sources along with rapid detection, characterization and management of TIC have been associated with improved outcomes. However, recent surveys confirm vast heterogeneity in the clinical diagnosis and management of acute trauma hemorrhage and TIC even in advanced trauma centers. In addition, conventional coagulation assays, although still used frequently during the early assessment of bleeding trauma patients, have their limitations. This narrative review highlights the clinical value of rapid point-of-care viscoelastic testing (VET) for the early diagnosis and individualized goal-directed therapy in bleeding trauma patients with TIC.
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PURPOSE: In the past, preinjury direct oral anticoagulant (DOAC) intake has led to delays in time to surgery (TTS) in patients with proximal femur fractures and delays in surgery have been associated with impaired outcomes. Although healthcare institutions/federal committees have set rules for treatment within 24 h of injury, comprehensive guidelines for the perioperative management of these patients, in particular when on preinjury DOACs, are still lacking. This contribution aims to summarize the current evidence on the safe time window for surgery in patients with proximal femur fractures on preinjury DOACs and to outline therapeutic options if emergency DOAC reversal becomes necessary. METHODS: Narrative review based upon selective review of the pertinent literature. RESULTS: For the majority of patients with proximal femur fractures and on preinjury DOACs, early surgery appears safe as soon as medical clearance has been obtained. There may be an increase in the need for blood products but with data not yet conclusive. Work-up including assessment of remaining anticoagulant activity and potential reversal should be restricted to patients at risk for bleeding complications, in particular in the presence of renal/hepatic impairment. Methodology for rapid assessment of DOACs including quantitative/qualitative concentration levels is work in progress. In the case of bleeding, rapidly acting reversal agents are available. CONCLUSION: Preinjury DOAC use should not routinely delay surgery in patients with proximal femur fractures.
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Anticoagulantes , Humanos , Anticoagulantes/efectos adversos , Anticoagulantes/administración & dosificación , Tiempo de Tratamiento , Administración Oral , Fracturas del Fémur/cirugía , Hemorragia , Fracturas de Cadera/cirugía , Inhibidores del Factor Xa/efectos adversos , Fracturas Femorales ProximalesRESUMEN
Improvements have been made in optimizing initial care of trauma patients, both in prehospital systems as well as in the emergency department, and these have also favorably affected longer term outcomes. However, as specific treatments for bleeding are largely lacking, many patients continue to die from hemorrhage. Also, major knowledge gaps remain on the impact of tissue injury on the host immune and coagulation response, which hampers the development of interventions to treat or prevent organ failure, thrombosis, infections or other complications of trauma. Thereby, trauma remains a challenge for intensivists. This review describes the most pressing research questions in trauma, as well as new approaches to trauma research, with the aim to bring improved therapies to the bedside within the twenty-first century.
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Servicios Médicos de Urgencia , Heridas y Lesiones , Humanos , Hemorragia/etiología , Coagulación Sanguínea , Servicio de Urgencia en Hospital , Heridas y Lesiones/terapia , Heridas y Lesiones/complicacionesRESUMEN
Trauma-induced coagulopathy (TIC) is a complex hemostatic disturbance that can develop early after a major injury. There is no universally accepted definition of TIC. However, TIC primarily refers to the inability to achieve sufficient hemostasis in severely injured trauma patients, resulting in diffuse microvascular and life-threatening bleeding. Endogenous TIC is driven by the combination of hypovolemic shock and substantial tissue injury, resulting in endothelial damage, glycocalyx shedding, upregulated fibrinolysis, fibrinogen depletion, altered thrombin generation, and platelet dysfunction. Exogenous factors such as hypothermia, acidosis, hypokalemia, and dilution due to crystalloid and colloid fluid administration can further exacerbate TIC. Established TIC upon emergency room admission is a prognostic indicator and is strongly associated with poor outcomes. It has been shown that patients with TIC are prone to higher bleeding tendencies, increased requirements for allogeneic blood transfusion, higher complication rates such as multi-organ failure, and an almost fourfold increase in mortality. Thus, early recognition and individualized treatment of TIC is a cornerstone of initial trauma care. However, patients who survive the initial insult switch from hypocoagulability to hypercoagulability, also termed "late TIC," with a high risk of developing thromboembolic complications.
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Trastornos de la Coagulación Sanguínea , Trastornos de las Plaquetas Sanguíneas , Hemostáticos , Heridas y Lesiones , Humanos , Hemostasis , Hemorragia/etiología , Fibrinólisis , Heridas y Lesiones/complicacionesRESUMEN
PURPOSE OF REVIEW: The diagnosis and treatment of patients with severe traumatic bleeding and subsequent trauma-induced coagulopathy (TIC) is still inconsistent, although the implementation of standardized algorithms/treatment pathways was repeatedly linked to improved outcome. Various evidence-based guidelines for these patients now exist, three of which have recently been updated. RECENT FINDINGS: A synopsis of the three recently updated guidelines for diagnosis and treatment of seriously bleeding trauma patients with TIC is presented: (i) AWMF S3 guideline 'Polytrauma/Seriously Injured Patient Treatment' under the auspices of the German Society for Trauma Surgery; (ii) guideline of the European Society of Anesthesiology and Intensive Care (ESAIC) on the management of perioperative bleeding; and (iii) European guideline on the management of major bleeding and coagulopathy after trauma in its 6th edition (EU-Trauma). SUMMARY: Treatment of trauma-related bleeding begins at the scene with local compression, use of tourniquets and pelvic binders and rapid transport to a certified trauma centre. After arrival at the hospital, measures to record, monitor and support coagulation function should be initiated immediately. Surgical bleeding control is carried out according to 'damage control' principles. Modern coagulation management includes individualized treatment based on target values derived from point-of-care viscoelastic test procedures.
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Trastornos de la Coagulación Sanguínea , Heridas y Lesiones , Humanos , Hemorragia/diagnóstico , Hemorragia/etiología , Hemorragia/terapia , Trastornos de la Coagulación Sanguínea/diagnóstico , Trastornos de la Coagulación Sanguínea/etiología , Trastornos de la Coagulación Sanguínea/terapia , Coagulación Sanguínea , Heridas y Lesiones/complicaciones , Heridas y Lesiones/terapiaRESUMEN
Contusion expansion (CE) is a potentially treatable outcome predictor in traumatic brain injury (TBI), and a suitable end-point for hemostatic therapy trials. However, there is no consensus on the definition of clinically relevant CE, both in terms of measurement criteria (absolute vs. relative volume increase) and cutoff values. In light of this, the aim of this study was to assess the predictive abilities of different CE definitions on outcome. We performed a multi-center observational cohort study of adults with moderate-to-severe TBI treated in an intensive care unit. The exposure of interest was CE, defined as the absolute and relative volume change between the first and second computed tomography scan. The primary outcome was the Glasgow Outcome Scale (GOS) at 6-12 months post-injury, dichotomized into unfavorable (GOS ≤3) or favorable (GOS ≥4). The secondary outcome was all-cause mortality. In total, 798 patients were included, with a median duration of 7.0 h between the first and second CT scan. The median absolute and relative CE was 1.5 mL (interquartile range [IQR] 0.1-8.3 mL) and 100% (IQR 10-530%), respectively. Both CE forms were independently associated with unfavorable GOS. Absolute CE outperformed relative CE in predicting both unfavorable GOS (area under the curve [AUC]: 0.65 vs. 0.60, p = 0.002) and all-cause mortality (AUC: 0.66 vs. 0.60, p = 0.003). For dichotomized CE, absolute cutoffs of 1-10 mL yielded the best results. We conclude that absolute CE demonstrates stronger outcome correlation than relative CE. In studies focusing on lesion progression in TBI, it may be advantageous to use absolute CE as the primary outcome metric. For dichotomized outcomes, cutoffs between 1 and 10 mL are suggested, depending on the desired sensitivity-specificity balance.
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Lesiones Traumáticas del Encéfalo , Contusiones , Adulto , Humanos , Lesiones Traumáticas del Encéfalo/diagnóstico por imagen , Área Bajo la Curva , Consenso , Estudios de CohortesRESUMEN
Background: The pathological mechanism of heat stroke (HS) involves the acute phase response, unbalanced immunological/inflammatory reactions, and coagulation initiation, especially platelet activation. Although exosomes contain proteins involved in these biological processes, their protein cargo levels and potential roles in HS remain unknown. This study explored the serum exosome protein expression patterns after HS and their potential roles in the pathogenesis of HS. Methods: Blood samples were collected from ten patients diagnosed with HS upon admission to the intensive care unit (six with severe HS and four with mild HS). Samples from six healthy volunteers were included as control. Using ultracentrifugation, exosomes were prudently isolated, and their protein contents were profiled using liquid chromatography-tandem mass spectrometry analysis with isobaric tags for relative and absolute quantification-based proteomics. Results: Compared with healthy volunteers, patients with HS showed significant changes in the levels of 33 exosomal proteins (23 upregulated and 10 downregulated). The most upregulated proteins included serum amyloid A-1 (SAA-1), von Willebrand factor (vWF), S100A8, and histone H3. In addition, SAA-1, vWF, platelet membrane glycoprotein, S100A8, and histone H3 were more enriched in the exosomes from patients with severe HS than from those with mild HS. Gene ontology analysis revealed that the HS-modulated exosomal proteins were mostly related to inflammatory response, including the acute-phase response, platelet activation/degranulation, and innate immune response. Kyoto Encyclopedia of Genes and Genomes pathway analysis revealed significant enrichment of proteins in the IL-17 signaling pathway, platelet activation, neutrophil extracellular trap formation, Fc epsilon RI signaling pathway, chemokine signaling pathway, and NOD-like receptor signaling pathway, among others. Several serum exosomal proteins, including SAA-1, vWF, and S100A8, which are related to the acute phase, inflammatory response, and platelet activation, were confirmed to be elevated in patients with HS, and were significantly correlated with disease severity, organ dysfunction, and death. Conclusion: Overall, this study explores the potential role of the serum exosomal proteome in the inflammatory response and platelet activation in HS, suggests the pathological mechanisms underlying HS-induced injuries, and recommends reliable exosomal biomarkers for predicting HS prognosis.
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Exosomas , Golpe de Calor , Insolación , Humanos , Reacción de Fase Aguda/metabolismo , Histonas/análisis , Exosomas/química , Factor de von Willebrand/análisis , Proteómica/métodos , Proteínas Sanguíneas/análisis , Activación Plaquetaria , Golpe de Calor/metabolismoRESUMEN
Objective: To define and contextualize life-threatening gastrointestinal (GI) bleeding in the setting of factor Xa (FXa) inhibitor therapy and to derive a consensus-based, clinically oriented approach to the administration of FXa inhibitor reversal therapy. Methods: We convened an expert panel of clinicians representing specialties in emergency medicine, gastroenterology, vascular medicine, and trauma surgery. Consensus was reached among the clinician panelists using the Delphi technique, which consisted of 2 survey questionnaires followed by virtual, real-time consensus-building exercises. Results: Hypovolemia and hemodynamic instability were considered the most important clinical signs of FXa inhibitor-related, life-threatening GI bleeds. Clinician panelists agreed that potentially life-threatening GI bleeding should be determined on the basis of hemodynamic instability, signs of shock, individual patient characteristics, and clinical judgment. Last, the panel agreed that all patients with life-threatening, FXa inhibitor-associated GI bleeding should be considered for FXa inhibitor reversal therapy; the decision to reverse FXa inhibition should be individualized, weighing the risks and benefits of reversal; and when reversal is elected, therapy should be administered within 1 h after initial emergency department evaluation, when possible. Conclusions: Consensus-based definitions of life-threatening GI bleeding and approaches to FXa inhibitor reversal centered on hemodynamic instability, signs of shock, individual patient characteristics, and clinical judgment. The results from this Delphi panel may inform clinical decision-making for the treatment of patients experiencing GI bleeding associated with FXa inhibitor use in the emergency department setting.
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BACKGROUND: Controversy surrounds the administration of blood products to severely traumatized patients before they arrive in the hospital in order to compensate for early blood loss and/or to correct coagulation disturbances that arise shortly after the traumatic event. A number of terrestrial and air rescue services have begun to provide this kind of treatment. METHODS: This review is based on articles using the PICO framework, published from January 2001 to January 2021, that were retrieved by a selective search, with structured searching strategies and searching bundles in Medline (OVIDSP), the Cochrane Central Register of Controlled Trials (CENTRAL), and Epistemonikos. A demand analysis was carried out on the basis of data from the trauma registry of the German Society of Trauma Surgery (TR-DGU) and practical experience from program development and implementation was provided by the Bundeswehr Hospital Ulm. RESULTS: The currently available evidence on the pre-hospital administration of blood products in the early treatment of severely injured patients is based largely on retrospective, single-center case series. Two randomized controlled trials (RCTs) concerning the early use of fresh frozen plasma concentrates have yielded partly conflicting results. Three further RCTs on the use of lyophilized plasma (lyplas), lyplas plus erythrocyte concentrate, or whole blood likewise revealed non-uniform effects on short-term and intermediate-term mortality. Our demand analysis based on data from the TR-DGU showed that 300 to 1800 patients per year in Germany could benefit from the pre-hospital administration of blood products. This might be indicated in patients who have systolic hypotension (<100 mmHg) in combination with a suspected or confirmed hemorrhage, as well as pathological shock parameters in the point-of-care diagnostic testing performed on the scene (serum base excess ≤ -2.5 mmol/L and/or serum lactate concentration >4 mmol/L). CONCLUSION: The studies that have been published to date yield no clear evidence either for or against the early pre-hospital administration of blood products. Any treatment of this kind should be accompanied by scientific evaluation.
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Hemorragia , Hospitales , Humanos , Hemorragia/terapia , Alemania/epidemiología , Estudios RetrospectivosRESUMEN
BACKGROUND: Whether prehospital administration of tranexamic acid increases the likelihood of survival with a favorable functional outcome among patients with major trauma and suspected trauma-induced coagulopathy who are being treated in advanced trauma systems is uncertain. METHODS: We randomly assigned adults with major trauma who were at risk for trauma-induced coagulopathy to receive tranexamic acid (administered intravenously as a bolus dose of 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital) or matched placebo. The primary outcome was survival with a favorable functional outcome at 6 months after injury, as assessed with the use of the Glasgow Outcome Scale-Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 ("upper good recovery" [no injury-related problems]). We defined survival with a favorable functional outcome as a GOS-E level of 5 ("lower moderate disability") or higher. Secondary outcomes included death from any cause within 28 days and within 6 months after injury. RESULTS: A total of 1310 patients were recruited by 15 emergency medical services in Australia, New Zealand, and Germany. Of these patients, 661 were assigned to receive tranexamic acid, and 646 were assigned to receive placebo; the trial-group assignment was unknown for 3 patients. Survival with a favorable functional outcome at 6 months occurred in 307 of 572 patients (53.7%) in the tranexamic acid group and in 299 of 559 (53.5%) in the placebo group (risk ratio, 1.00; 95% confidence interval [CI], 0.90 to 1.12; P = 0.95). At 28 days after injury, 113 of 653 patients (17.3%) in the tranexamic acid group and 139 of 637 (21.8%) in the placebo group had died (risk ratio, 0.79; 95% CI, 0.63 to 0.99). By 6 months, 123 of 648 patients (19.0%) in the tranexamic acid group and 144 of 629 (22.9%) in the placebo group had died (risk ratio, 0.83; 95% CI, 0.67 to 1.03). The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between the groups. CONCLUSIONS: Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo. (Funded by the Australian National Health and Medical Research Council and others; PATCH-Trauma ClinicalTrials.gov number, NCT02187120.).
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Antifibrinolíticos , Trastornos de la Coagulación Sanguínea , Servicios Médicos de Urgencia , Ácido Tranexámico , Heridas y Lesiones , Adulto , Humanos , Antifibrinolíticos/efectos adversos , Antifibrinolíticos/uso terapéutico , Australia , Ácido Tranexámico/efectos adversos , Ácido Tranexámico/uso terapéutico , Enfermedades Vasculares/etiología , Heridas y Lesiones/complicaciones , Trastornos de la Coagulación Sanguínea/etiologíaRESUMEN
BACKGROUND: Because of the aging population, the number of low falls in elderly people with pre-existing anticoagulation is rising, often leading to traumatic brain injury (TBI) with a social and economic burden. Hemostatic disorders and disbalances seem to play a pivotal role in bleeding progression. Interrelationships between anticoagulatoric medication, coagulopathy, and bleeding progression seem to be a promising aim of therapy. METHODS: We conducted a selective search of the literature in databases like Medline (Pubmed), Cochrane Library and current European treatment recommendations using relevant terms or their combination. RESULTS: Patients with isolated TBI are at risk for developing coagulopathy in the clinical course. Pre-injury intake of anticoagulants is leading to a significant increase in coagulopathy, so every third patient with TBI in this population suffers from coagulopathy, leading to hemorrhagic progression and delayed traumatic intracranial hemorrhage. In an assessment of coagulopathy, viscoelastic tests such as TEG or ROTEM seem to be more beneficial than conventional coagulation assays alone, especially because of their timely and more specific gain of information about coagulopathy. Furthermore, results of point-of-care diagnostic make rapid "goal-directed therapy" possible with promising results in subgroups of patients with TBI. CONCLUSIONS: The use of innovative technologies such as viscoelastic tests in the assessment of hemostatic disorders and implementation of treatment algorithms seem to be beneficial in patients with TBI, but further studies are needed to evaluate their impact on secondary brain injury and mortality.
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PURPOSE: In absence of comprehensive data collection on traumatic brain injury (TBI), the German Society for Neurosurgery (DGNC) and the German Society for Trauma Surgery (DGU) developed a TBI databank for German-speaking countries. METHODS: From 2016 to 2020, the TBI databank DGNC/DGU was implemented as a module of the TraumaRegister (TR) DGU and tested in a 15-month pilot phase. Since its official launch in 2021, patients from the TR-DGU (intermediate or intensive care unit admission via shock room) with TBI (AIS head ≥ 1) can be enrolled. A data set of > 300 clinical, imaging, and laboratory variables, harmonized with other international TBI data collection structures is documented, and the treatment outcome is evaluated after 6- and 12 months. RESULTS: For this analysis, 318 patients in the TBI databank could be included (median age 58 years; 71% men). Falls were the most common cause of injury (55%), and antithrombotic medication was frequent (28%). Severe or moderate TBI were only present in 55% of patients, while 45% suffered a mild injury. Nevertheless, intracranial pathologies were present in 95% of brain imaging with traumatic subarachnoid hemorrhages (76%) being the most common. Intracranial surgeries were performed in 42% of cases. In-hospital mortality after TBI was 21% and surviving patients could be discharged after a median hospital stay of 11 days. At the 6-and 12 months follow-up, a favorable outcome was achieved by 70% and 90% of the participating TBI patients, respectively. Compared to a European cohort of 2138 TBI patients treated in the ICU between 2014 and 2017, patients in the TBI databank were already older, frailer, fell more commonly at home. CONCLUSION: Within five years, the TBI databank DGNC/DGU of the TR-DGU could be established and is since then prospectively enrolling TBI patients in German-speaking countries. With its large and harmonized data set and a 12-month follow-up, the TBI databank is a unique project in Europe, already allowing comparisons to other data collection structures and indicating a demographic change towards older and frailer TBI patients in Germany.