FibrinogenFARDSNCT07664358
Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury
An observational study of Fibrinogen and Albumin, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrinogen, Albumin, ARDS
- What is being tested?
- Fibrinogen-to-albumin ratio
- How many people
- 350 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18 years admitted to the ICU within 24 hours of traumatic Brain Injury.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbia Governorate, 31527
Eman M Taher, MD, 01090822808 ext. 002, emantaher6669@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Fibrinogen, Albumin, ARDS, TBI (Traumatic Brain Injury)
- Being tested
- Fibrinogen-to-albumin ratio
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen-to-albumin ratioDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Diagnostic Test: Fibrinogen-to-albumin ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 7 days after traumatic brain injury.
Secondary outcomes (7)
Incidence of acute respiratory distress syndrome
Development of ARDS within 7 days of ICU admission, defined according to the Berlin criteria will be recorded.
Measured: 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.
Measured: 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.
Measured: Up to 30 days after traumatic brain injury.
ICU length of stay and mortality rate
Death during ICU stay or thereafter will be recorded.
Measured: 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.
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)
Measured: up to 7 days after traumatic brain injury.
Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome
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
Measured: up to 7 days after traumatic brain injury.
Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after 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.
Measured: Up to 90 days after traumatic brain injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrinogenStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohammed Taher Salem Abo-Omar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664358
- Sponsor's protocol ID
- 36265PR26/4/26
- Acronym
- FARDS
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07664358
- Acronym / sponsor ID
- FARDS / 36265PR26/4/26
- Conditions
- Fibrinogen, Albumin, ARDS, TBI (Traumatic Brain Injury)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute respiratory distress syndrome group | – | Diagnostic Test: Fibrinogen-to-albumin ratiopatients 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) |
| Non acute respiratory distress syndrome group | – | Diagnostic Test: Fibrinogen-to-albumin ratiopatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18 years admitted to the ICU within 24 hours of traumatic Brain Injury.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen-to-albumin ratioFibrinogen (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 | Acute respiratory distress syndrome group, Non acute respiratory distress syndrome group |
Primary outcome
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.
Time frame: 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)
7 secondary outcomes
Incidence of acute respiratory distress syndrome
Time frame: up to 7 days after traumatic brain injury.
Severity of acute respiratory distress syndrome.
Time frame: up to 7 days after traumatic brain injury.
Duration of mechanical ventilation
Time frame: Up to 30 days after traumatic brain injury.
ICU length of stay and mortality rate
Time frame: 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.
Time frame: up to 7 days after traumatic brain injury.
Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome
Time frame: up to 7 days after traumatic brain injury.
Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury
Time frame: Up to 90 days after traumatic brain injury.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.
Related trials for Fibrinogen
RecruitingPhase 4
Fibrinogen in Liver Transplant
Liver Transplant Surgery
Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
RecruitingPhase 3
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery
Acquired Fibrinogen Deficiency
Recruiting
Platelet-Rich Fibrinogen in Extraction Socket Healing of the Aged
Edentulism
RecruitingObservational study
Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions
Exanguination, Trauma Coagulopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrinogen and Albumin, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman M Taher, MD (01090822808 ext. 002, emantaher6669@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: up to 7 days after traumatic brain injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.