RESUMO
BACKGROUND: Patients with acute intracerebral hemorrhage who are receiving factor Xa inhibitors have a risk of hematoma expansion. The effect of andexanet alfa, an agent that reverses the effects of factor Xa inhibitors, on hematoma volume expansion has not been well studied. METHODS: We randomly assigned, in a 1:1 ratio, patients who had taken factor Xa inhibitors within 15 hours before having an acute intracerebral hemorrhage to receive andexanet or usual care. The primary end point was hemostatic efficacy, defined by expansion of the hematoma volume by 35% or less at 12 hours after baseline, an increase in the score on the National Institutes of Health Stroke Scale of less than 7 points (scores range from 0 to 42, with higher scores indicating worse neurologic deficit) at 12 hours, and no receipt of rescue therapy between 3 hours and 12 hours. Safety end points were thrombotic events and death. RESULTS: A total of 263 patients were assigned to receive andexanet, and 267 to receive usual care. Efficacy was assessed in an interim analysis that included 452 patients, and safety was analyzed in all 530 enrolled patients. Atrial fibrillation was the most common indication for factor Xa inhibitors. Of the patients receiving usual care, 85.5% received prothrombin complex concentrate. Hemostatic efficacy was achieved in 150 of 224 patients (67.0%) receiving andexanet and in 121 of 228 (53.1%) receiving usual care (adjusted difference, 13.4 percentage points; 95% confidence interval [CI], 4.6 to 22.2; P = 0.003). The median reduction from baseline to the 1-to-2-hour nadir in anti-factor Xa activity was 94.5% with andexanet and 26.9% with usual care (P<0.001). Thrombotic events occurred in 27 of 263 patients (10.3%) receiving andexanet and in 15 of 267 (5.6%) receiving usual care (difference, 4.6 percentage points; 95% CI, 0.1 to 9.2; P = 0.048); ischemic stroke occurred in 17 patients (6.5%) and 4 patients (1.5%), respectively. There were no appreciable differences between the groups in the score on the modified Rankin scale or in death within 30 days. CONCLUSIONS: Among patients with intracerebral hemorrhage who were receiving factor Xa inhibitors, andexanet resulted in better control of hematoma expansion than usual care but was associated with thrombotic events, including ischemic stroke. (Funded by Alexion AstraZeneca Rare Disease and others; ANNEXA-I ClinicalTrials.gov number, NCT03661528.).
Assuntos
Hemorragia Cerebral , Inibidores do Fator Xa , Fator Xa , Hematoma , Proteínas Recombinantes , Humanos , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/uso terapêutico , Idoso , Masculino , Feminino , Hemorragia Cerebral/tratamento farmacológico , Hemorragia Cerebral/induzido quimicamente , Pessoa de Meia-Idade , Proteínas Recombinantes/uso terapêutico , Proteínas Recombinantes/efeitos adversos , Fator Xa/uso terapêutico , Fator Xa/efeitos adversos , Hematoma/induzido quimicamente , Hematoma/tratamento farmacológico , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Doença AgudaRESUMO
This prospective, blinded, observational, efficacy study is one of the first to evaluate ultrasound in detecting esophageal intubation, a significant source of morbidity and mortality. We utilized a convenience sample of patients undergoing elective surgery during July 2004 in an urban teaching hospital. Trained Emergency Physician sonographers performed transtracheal ultrasounds of intubations to identify esophageal intubation. In 35 of the 40 patients enrolled, there was intubation of the trachea, whereas esophageal intubation occurred in five patients. Sonographers correctly identified all five esophageal intubations, for a sensitivity of 100% (95% confidence interval [CI] 48-100). Ultrasound correctly identified 34 of 35 tracheal intubations and misidentified one resulting in a specificity of 97% (95% CI 90-100). It seems that transtracheal ultrasound may be an efficacious adjunct for detecting esophageal intubation.
Assuntos
Intubação Intratraqueal/métodos , Laringe/diagnóstico por imagem , Traqueia/diagnóstico por imagem , Adulto , Serviço Hospitalar de Emergência , Esôfago , Hospitais de Ensino , Humanos , Capacitação em Serviço , Internato e Residência , Intubação Gastrointestinal , Intubação Intratraqueal/efeitos adversos , Salas Cirúrgicas , Estudos Prospectivos , Sensibilidade e Especificidade , Método Simples-Cego , UltrassonografiaRESUMO
We share the personal experience of an impaired resident who successfully completed rehabilitation and is about to graduate from an emergency medicine program and perform a brief literature review on drug and alcohol abuse in emergency medicine residencies. Residents in general are less likely than their same-age peers to abuse drugs, but a significant minority starts using drugs during residency. Emergency medicine residents have higher rates of substance use than residents in other specialties and are more likely to report current use of cocaine and marijuana.