[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644267":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":53,"overallOfficials":37,"centralContacts":59,"locations":66,"responsibleParty":83,"collaborators":37,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":37,"enrollmentInfo":97,"targetDuration":37,"studyType":100,"phases":37,"briefSummary":101,"conditions":102,"keywords":37,"overallStatus":69,"whyStopped":37,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002FL) and albumin (g\u002FL) 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\u002FL)\u002FAlbumin (g\u002FL)","up to 7 days after traumatic brain injury.",[14,17,20,24,28,31,34],{"measure":15,"description":16,"timeFrame":12},"Incidence of acute respiratory distress syndrome","Development of ARDS within 7 days of ICU admission, defined according to the Berlin criteria will be recorded.",{"measure":18,"description":19,"timeFrame":12},"Severity of acute respiratory distress syndrome.","It will be evaluated by the PaO2\u002FFiO2 ratio. PaO2\u002FFiO2 ratio between 200 and 300 will be considered mild ARDS. PaO2\u002FFiO2 ratio between 200 and 100 will be considered moderate ARDS. PaO2\u002FFiO2 ratio less than 100 will be considered severe ARDS.",{"measure":21,"description":22,"timeFrame":23},"Duration of mechanical ventilation","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.",{"measure":25,"description":26,"timeFrame":27},"ICU length of stay and mortality rate","Death during ICU stay or thereafter will be recorded.","Up to 90 days after traumatic brain injury.",{"measure":29,"description":30,"timeFrame":12},"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\u002FL) and albumin (g\u002FL) 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\u002FL)\u002FAlbumin (g\u002FL)",{"measure":32,"description":33,"timeFrame":12},"Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome","Fibrinogen (g\u002FL) and albumin (g\u002FL) 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:\n\nDelta 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",{"measure":35,"description":36,"timeFrame":27},"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.",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","PROSPECTIVE","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.\n\nAcute 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.\n\nThe 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.\n\nGiven 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.","Patients aged ≥ 18 years admitted to the ICU within 24 hours of traumatic Brain Injury.",[44,49],{"label":45,"type":37,"description":46,"interventionNames":47},"Acute respiratory distress syndrome group","patients who will develop ARDS within 7 days of ICU admission, defined according to the Berlin criteria. Fibrinogen (g\u002FL) and albumin (g\u002FL) levels in the blood will be measured from the first routine blood sample after ICU admission.\n\nFibrinogen-to-albumin ratio will be calculated as:\n\nFAR = Fibrinogen (g\u002FL)\u002FAlbumin (g\u002FL)",[48],"Diagnostic Test: Fibrinogen-to-albumin ratio",{"label":50,"type":37,"description":51,"interventionNames":52},"Non acute respiratory distress syndrome group","patients who will not develop ARDS within 7 days of ICU admission. Fibrinogen (g\u002FL) and albumin (g\u002FL) levels in the blood will be measured from the first routine blood sample after ICU admission.\n\nFibrinogen-to-albumin ratio will be calculated as:\n\nFAR = Fibrinogen (g\u002FL)\u002FAlbumin (g\u002FL)",[48],[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":37},"DIAGNOSTIC_TEST","Fibrinogen-to-albumin ratio","Fibrinogen (g\u002FL) and albumin (g\u002FL) levels in the blood will be measured from the first routine blood sample after ICU admission.\n\nFibrinogen-to-albumin ratio will be calculated as:\n\nFAR = Fibrinogen (g\u002FL)\u002FAlbumin (g\u002FL)",[45,50],[60],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Eman M Taher, MD","CONTACT","01090822808","002","emantaher6669@gmail.com",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Tanta University Hospitals","RECRUITING","Tanta","Gharbia Governorate","31527","Egypt","EG",{"type":76,"coordinates":77},"Point",[78,79],31.00192,30.78847,{"lat":79,"lon":78},[82],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Eman Mohammed Taher Salem Abo-Omar","lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university","100644267","fibrinogen-to-albumin-ratio-as-a-predictor-of-acute-respiratory-distress-syndrome-in-traumatic-brain-injury-100644267",false,"NCT07664358","Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury","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","FARDS","Inclusion Criteria:\n\n* Patients ≥ 18 years admitted to the ICU with traumatic Brain Injury\n* Admission to the ICU within 24 hours of injury.\n* Patients will be expected to remain under hospital care for follow-up\n* Availability of fibrinogen and albumin measurements within the first 24 hours of ICU admission.\n* Informed consent will be obtained from a legally authorized representative.\n\nExclusion Criteria:\n\n* Preexisting advanced chronic liver disease, nephrotic syndrome, or protein-losing enteropathy.\n* Pre-existing ARDS on admission.\n* Recipient of albumin, fibrinogen concentrate, or cryoprecipitate before admission sampling.\n* Use of anticoagulant or fibrinolytic therapy before admission.\n* Active malignancy or severe systemic infection at admission.\n* Direct sever lung injury\n* Pregnancy\n* Refusal of consent","ALL","18 Years",{"count":98,"type":99},350,"ESTIMATED","OBSERVATIONAL","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.",[103,104,105,106],"Fibrinogen","Albumin","ARDS","TBI (Traumatic Brain Injury)","2026-10-07",{"date":109,"type":110},"2026-10-09","ACTUAL",{"date":112,"type":110},"2026-07-01",{"date":114,"type":99},"2027-02-01",{"name":5,"class":6},1]