Ischemia Modified Albumin in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Ischemia
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT03637101
• Study type: Observational
• Source: Kasr El Aini Hospital
• Status: Completed
• Start date: June 15, 2018
• Completion date: December 7, 2018