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Outcome in Traumatic Brain Injury Elderly Patients

7 de diciembre de 2020 actualizado por: SEGUIN Philippe, Association pour la Recherche en Aanesthésie Réanimation Digestive

Factors Associated With Unfavorable Outcome in Traumatic Brain Injury Elderly Patients. A Retrospective Multicenter Study

In patients suffering from traumatic brain injury (TBI), the study's purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged ≥ 65 hospitalized in ICU and to compare outcome at 3 months between younger patients (18-64 years) vs older patients (≥65 years).

Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37% of all injury-related death in Europe. This was particularly true for patients ≥ 65 years old and in the most severe case(Glasgow coma score ≤ 8) with mortality rates between 31 to 51%. Over time, epidemiological patterns of TBI are changing. Indeed, in high-income countries, overall incidence is steadily decreasing, but increasing in elderly population with falls becoming the leading cause of TBI. In parallel, the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 (9%) million persons aged ≥65 years in the global population and that this proportion is projected to rise further to 16 % in 2050. Accordingly, we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades.

In a study performed in three neuro-intensive care unit (ICUs) from 1997 to 2007, 6-month mortality in patients aged of 70-79 and ≥ 80 years was 59% and 79%, respectively. In severe elderly (≥ 65 years) TBI patients admitted in ICU, hospital and 6-month mortality was 64.6% and 72.9%, respectively. Beyond mortality, TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities, frequent use of oral anticoagulants and/or antiplatelet and/or previous brain disorders. In patients hospitalized in ICU, age (> 59 years) was the strongest parameter associated with an unfavorable outcome including death, vegetative state and severe disability, at 6 month. Moreover, TBI elderly patients (≥ 65 years) had worse functional outcome at discharge than younger patients. Identifying elderly patients who may benefit from ICU remained challenging, since there is no consensual guideline of triage. Traumatic brain-injured patients are particularly concerned by this issue. Nevertheless, few data are available related to outcome in elderly TBI patients requiring ICU.

Descripción general del estudio

Estado

Terminado

Descripción detallada

The investigators conducted a multicentre, retrospective, observational study from April 2013 to February 2019 in the surgical ICUs of 5 level 1 Trauma centers in France. The investigators collected data from the "regional intensive care network of the great west of france" (AtlanRéa) database. The AtlanRéa database registers prospectively and consecutively numerous informations about brain injury and trauma patients hospitalized in ICUs, in order to provide epidemiologic informations for this population. Data were collected by clinical research assistants in each participating ICU, using an electronic case report form. The investigators assessed data regarding outcomes after discharge from ICUs through phone interview led by dedicated clinical research assistants.

The following data were entered in the database: Age, gender and body mass index, previous medical history, and more specifically the presence of cardiac insufficiency, chronic renal failure defined as an estimated glomerular filtration rate less than 60 ml/min.1.73 m-1, chronic respiratory illness, neurologic background, diabetes, neoplasia history, previous TBI, active smoking and chronic alcoholism. Mechanism of injury (domestic accident, road traffic crash, fall from heights or others). The Glasgow Coma Score (GCS) score determinates in the prehospital setting or at admission at hospital before intubation and/or sedation, and the presence of at least one nonreactive and dilated pupil at the initial management. Severity of illness according to the Simplified Acute Physiology Score II (SAPS II) the Sequential Organ Failure Assessment (SOFA) score, and the Injury Severity Score (ISS). The investigators also specified the severity of TBI by the abbreviated Injury Score (AIS) and reported the associated injuries from 5 territories (face, chest, abdomen, extremity (including pelvis) and external). Initial CT-scan was classified according to the Marshall classification in six categories (Diffuse injury I, II, III, IV, evacuated mass (V) and non-evacuated mass lesion (VI)).

The following data during the patients' hospitalization are also entered in the database: use of an intracranial pressure (ICP) catheter, occurrence of intracranial hypertension (defined as an ICP above 20 mmHg in absence of confounding factors), and use of barbiturates and/or osmotherapy, decompressive craniectomy, and other neurosurgical procedure. The occurrence of intercurrent events occurring during ICU stay, including infections, Acute Respiratory Distress Syndrome (ARDS), need of vasopressor drugs, acute renal failure, thrombophlebitis, pulmonary embolism, hemorrhage, infection and tracheostomy. The investigators specified the need for intubation and durations of mechanical ventilation, central venous catheterism and vasopressor. The investigators also recorded the decision in ICU to withdraw or withhold life support.

The length of stay in ICU, ICU and 3-month mortalities and patient outcome were assessed using the Glasgow Outcome Scale Extended (GOSE) score at 3 months. The investigators dichotomized the GOSE score between the four lower values (corresponding to unfavorable outcome- GOSE 1 to 4) and the four upper values (corresponding to favorable outcome- GOSE 5 to 8).

Statistical Analysis All statistical analysis will be performed using R software 3.3.1 (package pROC) and SAS 9.1 Statistical Software (SAS Institute, Cary, NC, USA). For quantitative continuous variables, position and dispersion parameters (mean, standard deviation, median, interquartile range) will be calculated. For qualitative variables, proportion rates will be calculated. For groups' comparison, we used independent-samples t-tests for normally distributed continuous variables, and Mann-Whitney U-tests for non-normally distributed continuous variables. Χ² tests will be performed for categorical variables. To build the model for multivariate analysis, the investigators selected among the variables with a p ≤ 0.20 according to the univariate analysis. The investigators performed logistic regression model to identify factors associated with in-ICU mortality and dichotomized GOSE score at 3 months. The Odds Ratios (ORs) and 95% confidence intervals (CI) will be calculated. For continuous variables, diagnosis of log linear behavior was established, and if not confirmed, the variable will be divided into categories and treated as categorical variables. Model's fit will be assessed by checking residual plots and Cook's distance. The calibration of the model will be tested by Goodness of Fit Hosmer-Lemeshow test. A p ≤0.05 will be considered statistically significant for all the comparisons.

Tipo de estudio

De observación

Inscripción (Actual)

1633

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Traumatic brain injury

Descripción

Inclusion Criteria:

  • Traumatic brain injury
  • Aged at least 18 years,
  • Hospitalized in intensive care unit

Exclusion Criteria:

  • Patients who die within 24h of hospitalization
  • Patients initially resuscitated awaiting for organ donation
  • Refusal for study participation expressed by the patient or relatives.
  • Missing data related to the main objective of the study (outcome at 3 months)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Traumatic brain injury patients
Traumatic brain injury patients admitted in intensive care unit.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Outcome was assessed using the Glasgow Outcome Scale Extended (GOSE) score
Periodo de tiempo: GOSE score at 3 months.
We dichotomized the GOSE score between the four lower values (corresponding to unfavorable outcome- GOSE 1 to 4) and the four upper values (corresponding to favorable outcome- GOSE 5 to 8).
GOSE score at 3 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Philippe Seguin, MD, PhD, AtlanRéa

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2013

Finalización primaria (Actual)

1 de junio de 2019

Finalización del estudio (Actual)

1 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

26 de noviembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

2 de diciembre de 2020

Publicado por primera vez (Actual)

3 de diciembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de diciembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

7 de diciembre de 2020

Última verificación

1 de diciembre de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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