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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TBI (Traumatic Brain Injury); ARDS; Fibrinogen Albumin Ratio
• Intervention / Treatment: Diagnostic test: Fibrinogen-to-albumin ratio

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.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Eman M Taher, MD; Phone Number: 002 01090822808; Email: emantaher6669@gmail.com

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31527
      • Tanta University Hospitals
      • Contact: Eman M Taher, MD; Phone Number: 002 01090822808; Email: emantaher6669@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	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)
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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute respiratory distress syndrome	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.	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	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 mortality	Death during ICU stay will be recorded.	Up to 30 days after traumatic brain injury.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 36265PR26/4/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
• IPD Sharing Time Frame: After the end of the study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No