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Идёт набор NCT07664358

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

Наблюдательное Fibrinogen Albumin ARDS TBI (Traumatic Brain Injury)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fibrinogen-to-albumin ratio.
Кому может быть актуально
Состояния в реестре: Fibrinogen, Albumin, ARDS, TBI (Traumatic Brain Injury). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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)

Первичные конечные точки

  • 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. [Срок оценки: up to 7 days after traumatic brain injury.]
Вторичные конечные точки (7)
  • Incidence of acute respiratory distress syndrome [Срок оценки: up to 7 days after traumatic brain injury.]
  • Severity of acute respiratory distress syndrome. [Срок оценки: up to 7 days after traumatic brain injury.]
  • Duration of mechanical ventilation [Срок оценки: Up to 30 days after traumatic brain injury.]
  • ICU length of stay and mortality rate [Срок оценки: 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. [Срок оценки: up to 7 days after traumatic brain injury.]
  • Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome [Срок оценки: up to 7 days after traumatic brain injury.]
  • Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury [Срок оценки: Up to 90 days after traumatic brain injury.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Tanta University Hospitals — Tanta

Идентификаторы

NCT: NCT07664358 · 36265PR26/4/26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗