Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury (FARDS)
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 исследования
Статус
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Eman M Taher, MD
- Номер телефона: 002 01090822808
- Электронная почта: emantaher6669@gmail.com
Места учебы
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Gharbia Governorate
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Tanta, Gharbia Governorate, Египет, 31527
- Рекрутинг
- Tanta University Hospitals
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Контакт:
- Eman M Taher, MD
- Номер телефона: 002 01090822808
- Электронная почта: emantaher6669@gmail.com
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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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) |
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) |
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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) |
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) |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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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.
Временное ограничение: up to 7 days after traumatic brain injury.
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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)
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up to 7 days after traumatic brain injury.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of acute respiratory distress syndrome
Временное ограничение: up to 7 days after traumatic brain injury.
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Development of ARDS within 7 days of ICU admission, defined according to the Berlin criteria will be recorded.
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up to 7 days after traumatic brain injury.
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Severity of acute respiratory distress syndrome.
Временное ограничение: up to 7 days after traumatic brain injury.
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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.
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up to 7 days after traumatic brain injury.
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Duration of mechanical ventilation
Временное ограничение: Up to 30 days after traumatic brain injury.
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patients who will require mechanical ventilation for management of hypoxemia will be evaluated for the duration of mechanical ventilation.
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Up to 30 days after traumatic brain injury.
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ICU length of stay and mortality rate
Временное ограничение: Up to 90 days after traumatic brain injury.
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Death during ICU stay or thereafter will be recorded.
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Up to 90 days after traumatic brain injury.
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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.
Временное ограничение: up to 7 days after traumatic brain injury.
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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)
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up to 7 days after traumatic brain injury.
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Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome
Временное ограничение: up to 7 days after traumatic brain injury.
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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.
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Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury
Временное ограничение: Up to 90 days after traumatic brain injury.
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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.
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Up to 90 days after traumatic brain injury.
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 36265PR26/4/26
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Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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