Fibrinogen-to-Albumin Ratio as a Predictor of ARDS in Traumatic Brain Injury
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
Run by Tanta University · NCT07664358 · Data updated 2026-11-12
This study tests whether the fibrinogen-to-albumin ratio can predict who among adults with traumatic brain injury will develop acute respiratory distress syndrome (ARDS).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | November 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07664358 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 years and older) with traumatic brain injury admitted to the ICU within 24 hours of injury and for whom fibrinogen and albumin measurements are available in the first 24 hours.
✕Probably not a fit
Patients without progression to ARDS or with ARDS from non-pibrinogen/albumin-influenced pathways may see limited direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will measure fibrinogen and albumin levels within 24 hours of ICU admission for adults with traumatic brain injury and examine how their ratio relates to the development of ARDS during the first week after injury. The goal is to see if the ratio can serve as an early biomarker to identify patients at higher risk. Data will be collected from patients at Tanta University Hospitals and analyzed to explore correlations with ARDS onset, severity, and timing. The study builds on existing evidence that inflammatory and coagulation pathways influence both traumatic injury outcomes and ARDS risk.
Why it matters
Potential benefit: If successful, clinicians may use the ratio to identify high-risk patients early and tailor monitoring or interventions to prevent or mitigate ARDS.
How similar studies have gone: Previous research has linked fibrinogen-to-albumin ratio to injury severity and outcomes in trauma, but its role as a predictor for ARDS in TBI is still emerging.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Tanta University Hospitals
Tanta, Gharbia Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Eman M Taher, MD
- Email: emantaher6669@gmail.com
- Phone: 01090822808
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.