Efficacy and Safety of Tinzaparin in Prophylactic, Intermediate and Therapeutic Doses in Non-Critically Ill Patients Hospitalized with COVID-19: The PROTHROMCOVID Randomized Controlled Trial.

Hospitalized patients with COVID-19 are at increased risk of thrombosis, acute respiratory distress syndrome and death. The optimal dosage of thromboprophylaxis is unknown. The aim was to evaluate the efficacy and safety of tinzaparin in prophylactic, intermediate, and therapeutic doses in non-critical patients admitted for COVID-19 pneumonia. PROTHROMCOVID is a randomized, unblinded, controlled, multicenter trial enrolling non-critical, hospitalized adult patients with COVID-19 pneumonia. Patients were randomized to prophylactic (4500 IU), intermediate (100 IU/kg), or therapeutic (175 IU/kg) groups. All tinzaparin doses were administered once daily during hospitalization, followed by 7 days of prophylactic tinzaparin at discharge. The primary efficacy outcome was a composite endpoint of symptomatic systemic thrombotic events, need for invasive or non-invasive mechanical ventilation, or death within 30 days. The main safety outcome was major bleeding at 30 days. Of the 311 subjects randomized, 300 were included in the prespecified interim analysis (mean [SD] age, 56.7 [14.6] years; males, 182 [60.7%]). The composite endpoint at 30 days from randomization occurred in 58 patients (19.3%) of the total population; 19 (17.1 %) in the prophylactic group, 20 (22.1%) in the intermediate group, and 19 (18.5%) in the therapeutic dose group (p = 0.72). No major bleeding event was reported; non-major bleeding was observed in 3.7% of patients, with no intergroup differences. Due to these results and the futility analysis, the trial was stopped. In non-critically ill COVID-19 patients, intermediate or full-dose tinzaparin compared to standard prophylactic doses did not appear to affect the risk of thrombotic event, non-invasive ventilation, or mechanical ventilation or death. Trial RegistrationClinicalTrials.gov Identifier (NCT04730856). Edura-CT registration number: 2020-004279-42.

Comparación del indicador Quick SOFA respecto a los niveles asignados por el Modelo Andorrano de Triaje en la clasificación de los pacientes que acuden a un servicio de urgencias de un hospital urbano de tercer nivel / Comparison of the Quick Sepsis-related Organ Dysfunction score and severity levels assigned with the Andorran Triage Model in an urban tertiary care hospital emergency department

Objetivo. Comparar la utilidad pronóstica del "quick SOFA" (qSOFA) con respecto al nivel de triaje asignado por el Modelo Andorrano de Triaje (MAT) en un servicio de urgencias hospitalario (SUH). Método. Durante seis meses se incluyó a los pacientes que en la primera hora del turno de mañana consultaron en urgencias de un hospital terciario y fueron clasificados como nivel 2 o nivel 3 según el MAT. Se realizó seguimiento prospectivo del episodio de urgencias y del episodio de ingreso de aquellos pacientes que lo requirieron. Se analizó la mortalidad a 30 días mediante curvas de Kaplan-Meier y análisis multivariante mediante regresión de Cox. Resultados. Se incluyeron 322 pacientes (edad media de 61 años). El valor del qSOFA a la llegada a urgencias fue de 0-1 puntos en 294 (91%) y de 2-3 puntos en 28 pacientes (9%). Un total de 14 pacientes fallecieron como consecuencia del episodio que motivó su asistencia en urgencias, y la probabilidad de supervivencia a los 30 días fue del 97%. Los factores relacionados con mayor mortalidad fueron el nivel 2 de triaje, el valor de qSOFA 2-3 puntos, la edad igual o mayor de 70 años y un índice Charlson abreviado de comorbilidad >= 4 puntos. En el análisis de regresión de Cox, un valor de qSOFA 2-3 fue el único factor asociado de forma independiente a mayor mortalidad. Conclusiones. El qSOFA es un indicador útil en el triaje de los pacientes que acuden a un SUH, puesto que identifica de forma independiente a los que tienen un peor pronóstico

Objective. To compare the usefulness of the Quick Sepsis-related Organ Dysfunction (qSOFA) score and the Andorran Triage Model in a hospital emergency department. Methods. Patients who came to emergency department of a tertiary-eme hospital during the first hour of the morning shift over a 6-month period were included in the study if severity was assessed as level 2 or 3 according to the Andorran model. The qSOFA score was also assessed on arrival. The patients were then followed prospectively in the department and if they were admitted, follow-up continued on the ward. Thirty-day mortality was analyzed with Kaplan-Meier curves and the Cox multiple-variable regression model. Results. A total of 322 patients with a mean age of 61 years were included. The qSOFA scores on arrival in the department were 0-1 points in 294 patients (91%) and 2-3 points in 28 (9%). Fourteen patients died as a consequence of the emergency. The 30-day probability of survival was calculated to be 97%. Factors related to mortality were level-2 triage classification, a qSOFA score of 2-3 points, age 70 years or older, and an abbreviated Charlson index of 4 points or higher. A qSOFA score of 2-3 points was the only independent variable associated with mortality in the Cox model. Conclusion. The qSOFA score is a useful triage indicator in patients who come to a hospital emergency department. It identifies patients with a worse prognosis

Comparison of the Quick Sepsis-related Organ Dysfunction score and severity levels assigned with the Andorran Triage Model in an urban tertiary care hospital emergency department. / Comparación del indicador Quick SOFA respecto a los niveles asignados por el Modelo Andorrano de Triaje en la clasificación de los pacientes que acuden a un servicio de urgencias de un hospital urbano de tercer nivel.

OBJECTIVES: To compare the usefulness of the Quick Sepsis-related Organ Dysfunction (qSOFA) score and the Andorran Triage Model in a hospital emergency department. MATERIAL AND METHODS: Patients who came to emergency department of a tertiary-eme hospital during the first hour of the morning shift over a 6-month period were included in the study if severity was assessed as level 2 or 3 according to the Andorran model. The qSOFA score was also assessed on arrival. The patients were then followed prospectively in the department and if they were admitted, follow-up continued on the ward. Thirty-day mortality was analyzed with Kaplan-Meier curves and the Cox multiple-variable regression model. RESULTS: A total of 322 patients with a mean age of 61 years were included. The qSOFA scores on arrival in the department were 0-1 points in 294 patients (91%) and 2-3 points in 28 (9%). Fourteen patients died as a consequence of the emergency. The 30-day probability of survival was calculated to be 97%. Factors related to mortality were level-2 triage classification, a qSOFA score of 2-3 points, age 70 years or older, and an abbreviated Charlson index of 4 points or higher. A qSOFA score of 2-3 points was the only independent variable associated with mortality in the Cox model. CONCLUSION: The qSOFA score is a useful triage indicator in patients who come to a hospital emergency department. It identifies patients with a worse prognosis.

OBJETIVO: Comparar la utilidad pronóstica del 'quick SOFA' (qSOFA) con respecto al nivel de triaje asignado por el Modelo Andorrano de Triaje (MAT) en un servicio de urgencias hospitalario (SUH). METODO: Durante seis meses se incluyó a los pacientes que en la primera hora del turno de mañana consultaron en urgencias de un hospital terciario y fueron clasificados como nivel 2 o nivel 3 según el MAT. Se realizó seguimiento prospectivo del episodio de urgencias y del episodio de ingreso de aquellos pacientes que lo requirieron. Se analizó la mortalidad a 30 días mediante curvas de Kaplan-Meier y análisis multivariante mediante regresión de Cox. RESULTADOS: Se incluyeron 322 pacientes (edad media de 61 años). El valor del qSOFA a la llegada a urgencias fue de 0-1 puntos en 294 (91%) y de 2-3 puntos en 28 pacientes (9%). Un total de 14 pacientes fallecieron como consecuencia del episodio que motivó su asistencia en urgencias, y la probabilidad de supervivencia a los 30 días fue del 97%. Los factores relacionados con mayor mortalidad fueron el nivel 2 de triaje, el valor de qSOFA 2-3 puntos, la edad igual o mayor de 70 años y un índice Charlson abreviado de comorbilidad 4 puntos. En el análisis de regresión de Cox, un valor de qSOFA 2-3 fue el único factor asociado de forma independiente a mayor mortalidad. CONCLUSIONES: El qSOFA es un indicador útil en el triaje de los pacientes que acuden a un SUH, puesto que identifica de forma independiente a los que tienen un peor pronóstico.