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

NCT07664358 | Recruiting

• 1 other identifier: 36265PR26/4/26
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibrinogen; Albumin; ARDS; TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of acute respiratory distress syndrome

  up to 7 days after traumatic brain injury.

• Severity of acute respiratory distress syndrome.

  up to 7 days after traumatic brain injury.

• Duration of mechanical ventilation

  Up to 30 days after traumatic brain injury.

• ICU length of stay and mortality rate

  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.

  up to 7 days after traumatic brain injury.

Study Arms (2)

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

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

Interventions

Fibrinogen-to-albumin ratio DIAGNOSTIC_TEST

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)

Acute respiratory distress syndrome group; Non acute respiratory distress syndrome group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Eman M Taher, MD

CONTACT

01090822808; emantaher6669@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the end of the study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)