Ischemia Modified Albumin in Traumatic Brain Injury

K

Kasr El Aini Hospital

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Diagnostic Test: Ischemia modified albumin (IMA)

Study type

Observational

Funder types

Other

Identifiers

NCT03637101
N-23-2018

Details and patient eligibility

About

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.

Full 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

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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