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Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury (FARDS)

1 juli 2026 bijgewerkt door: Eman Mohammed Taher Salem Abo-Omar, Tanta University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

350

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Egypte
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypte, 31527
        • Werving
        • Tanta University Hospitals
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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)
Diagnostische toets: 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)
Diagnostische toets: 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)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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.
Tijdsspanne: up to 7 days after traumatic brain injury.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of acute respiratory distress syndrome
Tijdsspanne: up to 7 days after traumatic brain injury.
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.
Tijdsspanne: up to 7 days after traumatic brain injury.
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
Tijdsspanne: Up to 30 days after traumatic brain injury.
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 length of stay and mortality rate
Tijdsspanne: Up to 90 days after traumatic brain injury.
Death during ICU stay or thereafter will be recorded.
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.
Tijdsspanne: up to 7 days after traumatic brain injury.
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)
up to 7 days after traumatic brain injury.
Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome
Tijdsspanne: up to 7 days after traumatic brain injury.

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.
Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury
Tijdsspanne: Up to 90 days after traumatic brain injury.
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.
Up to 90 days after traumatic brain injury.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tanta University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2026

Primaire voltooiing (Geschat)

1 oktober 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

17 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juni 2026

Eerst geplaatst (Werkelijk)

24 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 36265PR26/4/26

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.

IPD-tijdsbestek voor delen

After the end of the study for one year.

IPD-toegangscriteria voor delen

The data will be available upon a reasonable request from the corresponding author.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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