Clinical trial NCT03637101: Ischemia Modified Albumin in Traumatic Brain Injury
Official title: Ischemia Modified Albumin as a Biomarker for Prediction of Poor Outcome in Patients With Traumatic Brain Injury. Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Ischemia modified albumin
Traumatic brain injury
Troponin
Conscious Level
Poor outcome
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who were admitted to the trauma and neurosurgical ICU with isolated traumatic brain injury

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between IMA and mortality following TBI
timeFrame: 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 outcomes:
measure: Correlation between 24 hours IMA and mortality following TBI
timeFrame: 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
measure: The incidence of patients with elevated IMA
timeFrame: IMA on admission to ICU and after 24 hours
measure: The degree of correlation between severity of TBI and IMA
timeFrame: Glasgow coma scale immediately on admission to the ICU, IMA will be collected on admission to ICU and after 24 hours
measure: The degree of correlation between mild TBI and ICU length of stay
timeFrame: The number of days in ICU till discharge or mortality up to 28 days post admission
measure: The degree of correlation between moderate TBI and ICU length of stay
timeFrame: The number of days in ICU till discharge or mortality up to 28 days post admission
measure: The degree of correlation between severe TBI and ICU length of stay
timeFrame: The number of days in ICU till discharge or mortality up to 28 days post admission
measure: The degree of correlation between severity of TBI and and deterioration of conscious level
timeFrame: Glasgow coma scale immediately on admission to the ICU and daily till mortality or discharge up to 28 days post admission
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Aini Hospital
Study officials:
References:
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citation: Hasanin A, Kamal A, Amin S, Zakaria D, El Sayed R, Mahmoud K, Mukhtar A. Incidence and outcome of cardiac injury in patients with severe head trauma. Scand J Trauma Resusc Emerg Med. 2016 Apr 27;24:58. doi: 10.1186/s13049-016-0246-z.
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