Ischemia Modified Albumin in Traumatic Brain Injury

Study Overview
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Brief Summary
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In the current study the investigators intend to evaluate the role of Ischemia modified albumin (IMA) in the prediction of poor outcome in patients with traumatic brain injury (TBI). The investigators hypothesize that IMA will be elevated in patients with traumatic brain injury due to the excessive production of reactive oxygen species by the injured brain.

Detailed Description
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Consecutive adult patients who were admitted with TBI, blood samples were taken once written informed consent obtained. Initial evaluation on admission was performed simultaneously by ICU physician and a neurosurgical resident by means of a detailed physical and neurological examination. Demographic characteristics and vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and peripheral ischemic disease) were recorded in details. Also, Routine blood tests, including full blood count, coagulation tests, glucose level, renal and hepatic function tests, total protein, and albumin levels; chest radiography were done. CT scan will be performed in all the cases for the confirmation of TBI. Glasgow coma scale (GCS) was assessed on admission and recorded and assessed daily to evaluate prognosis. Patients were monitored by BP, ECG, and Pulse oximetry. All patients received standard medical treatment which included anti-edema measures mannitol 20%, 0.25-0.5 g/kg over 20 min, (not exceeding a total of 2 g/kg of body weight in 24 h) in patients with symptoms of raised intracranial pressure, and other supportive therapy for the treatment of concurrent illnesses such as hypertension and diabetes mellitus. Biochemical Assessments: Blood samples from TBI patients were collected immediately at the time of admission to the ICU and 24 hours later. Samples were centrifuged at 2500 RPM for 15 minutes and obtained serum samples were stored at -20oC. IMA was measured by the colorimetric method and results were presented in absorbance units (ABSU). Data collection Patients' characteristics: age, gender, BMI, cause of ICU admission. IMA will be measured at time of admission to ICU and 24h later Other data collections: Hear rate (HR), systolic blood pressure,central venous pressure (CVP), body temperature. All hemodynamic parameters were measured and recorded at time of admission and every 2 hours for 24 hours Length of ICU stay 28-day mortality Troponin I level on admission. GCS at admission and daily till mortality or discharge

Official Title
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Ischemia Modified Albumin as a Biomarker for Prediction of Poor Outcome in Patients With Traumatic Brain Injury. Observational Cohort Study

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Diagnostic Test: Ischemia modified albumin (IMA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 years old Patients with isolated head injury Exclusion Criteria: Age < 18 years old Pregnant patient Acute hepatitis or severe liver disease (Child-Pugh class C) Patients with recent pulmonary embolism Patients with unstable angina or recent myocardial infarction (MI) Peripheral arterial disease Acute stroke Chronic renal failure (CRF) Hypoalbuminemia less than 3.5 Patients with other organs injury Penetrating head injury Head trauma more than 24 hours before admission Patients with known inflammatory or autoimmune diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ischemia modified albumin (IMA)|Ischemia modified albumin is a biomarker for cardiac ischemia and acute stroke whether ischemic or hemorrhagic|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between IMA and mortality following TBI | IMA in ng/ml will be measured at time of admission to ICU and correlated with 28 day mortality | The number of patients who died within 28 days from admission to ICU after TBI and who were investigated for IMA upon admission to ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between 24 hours IMA and mortality following TBI | IMA in ng/ml will be measured 24 hours after admission to ICU and correlated with 28 day mortality | The number of patients who died within 28 days from admission to ICU after TBI and who were investigated for IMA 24 hours after admission to ICU | 
| The incidence of patients with elevated IMA | The percentage of patients having elevated IMA in ng/ml from the recruited patients with traumatic brain injuries. | IMA on admission to ICU and after 24 hours | 
| The degree of correlation between severity of TBI and IMA | The severity of traumatic brain injury classified by Glasgow Coma Scale as mild 13-15, moderate 9-12 or severe 3-8 and the IMA levels in ng/ml in those patients. | Glasgow coma scale immediately on admission to the ICU, IMA will be collected on admission to ICU and after 24 hours | 
| The degree of correlation between mild TBI and ICU length of stay | The number of days spent in ICU for patients with mild TBI (GCS 13-15) | The number of days in ICU till discharge or mortality up to 28 days post admission | 
| The degree of correlation between moderate TBI and ICU length of stay | The number of days spent in ICU for patients with moderate TBI (GCS 9-12) | The number of days in ICU till discharge or mortality up to 28 days post admission | 
| The degree of correlation between severe TBI and ICU length of stay | The number of days spent in ICU for patients with severe TBI (GCS 3- 8) | The number of days in ICU till discharge or mortality up to 28 days post admission | 
| The degree of correlation between severity of TBI and and deterioration of conscious level | The severity of traumatic brain injury classified by Glasgow Coma Scale as mild 13-15, moderate 9-12 or severe 3-8 on admission and the Glasgow coma scale on the following days in the ICU til mortality or discharge | Glasgow coma scale immediately on admission to the ICU and daily till mortality or discharge up to 28 days post admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia modified albumin, Traumatic brain injury, Troponin, Conscious Level, Poor outcome