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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Fibrinogen-to-albumin ratio (Diagnostic Test)
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)
干预措施: Fibrinogen-to-albumin ratio (Diagnostic Test)
结局指标
主要结局
未指定
次要结局
- ICU length of stay and mortality rate(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.(up to 7 days after traumatic brain injury.)
- Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome(up to 7 days after traumatic brain injury.)
- Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury(Up to 90 days after traumatic brain injury.)
研究者
Eman Mohammed Taher Salem Abo-Omar
lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university
Tanta University