Ischemia Modified Albumin in Traumatic Brain Injury

January 13, 2019 updated by: Rania Samir Fahmy, Kasr El Aini Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr El Aini Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients who were admitted to the trauma and neurosurgical ICU with isolated traumatic brain injury

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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.
IMA on admission to ICU and after 24 hours
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.
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
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)
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
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)
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
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)
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
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
Glasgow coma scale immediately on admission to the ICU and daily till mortality or discharge up to 28 days post admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2018

Primary Completion (ACTUAL)

December 7, 2018

Study Completion (ACTUAL)

December 7, 2018

Study Registration Dates

First Submitted

August 4, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (ACTUAL)

August 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-23-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

Clinical Trials on Ischemia modified albumin (IMA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe