Skip to main content
OpenTrials
Completed

NCT Number: NCT03637101

Ischemia Modified Albumin in Traumatic Brain Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr El Aini Hospital

Cairo, 11562, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischemia modified albumin (IMA)

Diagnostic Test

Ischemia modified albumin is a biomarker for cardiac ischemia and acute stroke whether ischemic or hemorrhagic

Primary outcomes

  1. Correlation between IMA and mortality following TBI

    Time frame: 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

    IMA in ng/ml will be measured at time of admission to ICU and correlated with 28 day mortality

Secondary outcomes

  1. Correlation between 24 hours IMA and mortality following TBI

    Time frame: 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

    IMA in ng/ml will be measured 24 hours after admission to ICU and correlated with 28 day mortality

  2. The incidence of patients with elevated IMA

    Time frame: IMA on admission to ICU and after 24 hours

    The percentage of patients having elevated IMA in ng/ml from the recruited patients with traumatic brain injuries.

  3. The degree of correlation between severity of TBI and IMA

    Time frame: Glasgow coma scale immediately on admission to the ICU, IMA will be collected on admission to ICU and after 24 hours

    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.

  4. The degree of correlation between mild TBI and ICU length of stay

    Time frame: The number of days in ICU till discharge or mortality up to 28 days post admission

    The number of days spent in ICU for patients with mild TBI (GCS 13-15)

  5. The degree of correlation between moderate TBI and ICU length of stay

    Time frame: The number of days in ICU till discharge or mortality up to 28 days post admission

    The number of days spent in ICU for patients with moderate TBI (GCS 9-12)

  6. The degree of correlation between severe TBI and ICU length of stay

    Time frame: The number of days in ICU till discharge or mortality up to 28 days post admission

    The number of days spent in ICU for patients with severe TBI (GCS 3- 8)

  7. The degree of correlation between severity of TBI and and deterioration of conscious level

    Time frame: Glasgow coma scale immediately on admission to the ICU and daily till mortality or discharge up to 28 days post admission

    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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2018
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.