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Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury (FARDS)

1 de julio de 2026 actualizado por: Eman Mohammed Taher Salem Abo-Omar, Tanta University

Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Patients With Traumatic Brain Injury: The Prospective, Observational, Multi-center FARDS Study

this study aims to assess the ability of fibrinogen-to-albumin ratio to predict the development of Acute respiratory distress syndrome in traumatic brain injury patients.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Traumatic brain injury is a major cause of morbidity and mortality worldwide and represents a significant challenge in intensive care units. In addition to the primary neurological damage, patients with moderate to severe traumatic brain injury frequently develop systemic inflammatory responses that may lead to secondary organ dysfunction. These systemic effects are mediated by activation of inflammatory cytokines, endothelial injury, and coagulation abnormalities.

Acute respiratory distress syndrome is a common and serious complication in patients with traumatic brain injury, even in the absence of direct chest trauma. Epidemiological studies indicate that acute respiratory distress syndrome develops in approximately 19-30% of severe traumatic brain injury patients, typically within the first week after injury, with a median time to onset of around 3 days.

The fibrinogen-to-albumin ratio has recently emerged as a novel biomarker reflecting both inflammatory and nutritional status. Fibrinogen is a positive acute-phase reactant that increases in response to inflammation and tissue injury, while albumin is a negative acute-phase protein that decreases during systemic inflammatory states. Previous studies have demonstrated that fibrinogen-to-albumin ratio is altered in patients with traumatic brain injury and correlates with injury severity and clinical outcomes.

Given that the same inflammatory and coagulation pathways influencing fibrinogen-to-albumin ratio in traumatic brain injury also play a central role in the development of acute respiratory distress syndrome, it is biologically plausible that early fibrinogen-to-albumin ratio measurements may predict acute respiratory distress syndrome occurrence in this patient population. However, the predictive value of fibrinogen-to-albumin ratio for acute respiratory distress syndrome in patients with traumatic brain injury has not yet been adequately investigated.

Tipo de estudio

De observación

Inscripción (Estimado)

350

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Egipto
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egipto, 31527
        • Reclutamiento
        • Tanta University Hospitals
        • Contacto:

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

Patients aged ≥ 18 years admitted to the ICU within 24 hours of traumatic Brain Injury.

Descripción

Inclusion Criteria:

  • Patients ≥ 18 years admitted to the ICU with traumatic Brain Injury
  • Admission to the ICU within 24 hours of injury.
  • Patients will be expected to remain under hospital care for follow-up
  • Availability of fibrinogen and albumin measurements within the first 24 hours of ICU admission.
  • Informed consent will be obtained from a legally authorized representative.

Exclusion Criteria:

  • Preexisting advanced chronic liver disease, nephrotic syndrome, or protein-losing enteropathy.
  • Pre-existing ARDS on admission.
  • Recipient of albumin, fibrinogen concentrate, or cryoprecipitate before admission sampling.
  • Use of anticoagulant or fibrinolytic therapy before admission.
  • Active malignancy or severe systemic infection at admission.
  • Direct sever lung injury
  • Pregnancy
  • Refusal of consent

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
Intervención / Tratamiento
Acute respiratory distress syndrome group

patients who will develop ARDS within 7 days of ICU admission, defined according to the Berlin criteria. Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)
Prueba de diagnóstico: Fibrinogen-to-albumin ratio

Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)
Non acute respiratory distress syndrome group

patients who will not develop ARDS within 7 days of ICU admission. Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)
Prueba de diagnóstico: Fibrinogen-to-albumin ratio

Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The accuracy of early fibrinogen-to-albumin ratio (within 24 hours of ICU admission) to predict the development of acute respiratory distress syndrome in traumatic brain injury patients.
Periodo de tiempo: up to 7 days after traumatic brain injury.
Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission. Fibrinogen-to-albumin ratio will be calculated as: FAR = Fibrinogen (g/L)/Albumin (g/L)
up to 7 days after traumatic brain injury.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of acute respiratory distress syndrome
Periodo de tiempo: up to 7 days after traumatic brain injury.
Development of ARDS within 7 days of ICU admission, defined according to the Berlin criteria will be recorded.
up to 7 days after traumatic brain injury.
Severity of acute respiratory distress syndrome.
Periodo de tiempo: up to 7 days after traumatic brain injury.
It will be evaluated by the PaO2/FiO2 ratio. PaO2/FiO2 ratio between 200 and 300 will be considered mild ARDS. PaO2/FiO2 ratio between 200 and 100 will be considered moderate ARDS. PaO2/FiO2 ratio less than 100 will be considered severe ARDS.
up to 7 days after traumatic brain injury.
Duration of mechanical ventilation
Periodo de tiempo: Up to 30 days after traumatic brain injury.
patients who will require mechanical ventilation for management of hypoxemia will be evaluated for the duration of mechanical ventilation.
Up to 30 days after traumatic brain injury.
ICU length of stay and mortality rate
Periodo de tiempo: Up to 90 days after traumatic brain injury.
Death during ICU stay or thereafter will be recorded.
Up to 90 days after traumatic brain injury.
The accuracy of fibrinogen-to-albumin ratio measured at 24 hours and 48 hours after injury to predict the development of acute respiratory distress syndrome in traumatic brain injury patients.
Periodo de tiempo: up to 7 days after traumatic brain injury.
Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured at 24 hours and 48 hours after injury. Fibrinogen-to-albumin ratio will be calculated as: FAR = Fibrinogen (g/L)/Albumin (g/L)
up to 7 days after traumatic brain injury.
Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome
Periodo de tiempo: up to 7 days after traumatic brain injury.

Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured on admission and at 24 hours and 48 hours after injury. Delta fibrinogen-to-albumin ratio will be calculated as:

Delta FAR (24h-0h) = FAR at 24h -FAR on admission Delta FAR (48h-0h) = FAR at 48h -FAR on admission Delta FAR (48h-24h)= FAR at 48h -FAR at 24h
up to 7 days after traumatic brain injury.
Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury
Periodo de tiempo: Up to 90 days after traumatic brain injury.
Neurological outcomes will be assessed by the Glasgow Outcome Score (GOS). The score is as follows: 1 = dead; 2 = vegetative state with an inability to interact with the environment; 3 = severe disability with an inability to live independently but the ability to follow commands; 4 = moderate disability with the ability to live independently but an inability to return to work or school; and 5 = good recovery with the ability to return to work or school. A GOS of 1-3 was categorized as an unfavorable outcome, whereas a score of 4-5 was deemed a favorable outcome.
Up to 90 days after traumatic brain injury.

Colaboradores e Investigadores

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

Patrocinador

Tanta University

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 julio de 2026

Finalización primaria (Estimado)

1 de octubre de 2026

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

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

1 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 36265PR26/4/26

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.

Marco de tiempo para compartir IPD

After the end of the study for one year.

Criterios de acceso compartido de IPD

The data will be available upon a reasonable request from the corresponding author.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

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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