Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fibrinogen-to-albumin ratio.
- Who it may be relevant to
- Registry conditions: Fibrinogen, Albumin, ARDS, TBI (Traumatic Brain Injury). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test 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)
Primary outcome measures
- 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. [Time frame: up to 7 days after traumatic brain injury.]
Secondary outcome measures (7)
- Incidence of acute respiratory distress syndrome [Time frame: up to 7 days after traumatic brain injury.]
- Severity of acute respiratory distress syndrome. [Time frame: up to 7 days after traumatic brain injury.]
- Duration of mechanical ventilation [Time frame: Up to 30 days after traumatic brain injury.]
- ICU length of stay and mortality rate [Time frame: 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. [Time frame: up to 7 days after traumatic brain injury.]
- Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome [Time frame: up to 7 days after traumatic brain injury.]
- Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury [Time frame: Up to 90 days after traumatic brain injury.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Tanta University Hospitals — Tanta
Identifiers
NCT: NCT07664358 · 36265PR26/4/26