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

1 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

350

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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)
Test diagnostique: 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)
Test diagnostique: 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)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of acute respiratory distress syndrome
Délai: 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.
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tanta University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juillet 2026

Achèvement primaire (Estimé)

1 octobre 2026

Achèvement de l'étude (Estimé)

1 janvier 2027

Dates d'inscription aux études

Première soumission

17 juin 2026

Première soumission répondant aux critères de contrôle qualité

17 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 36265PR26/4/26

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

After the end of the study for one year.

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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