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Traumatic Brain InjuryNCT03637101

Ischemia Modified Albumin in Traumatic Brain Injury

An observational study of Traumatic Brain Injury, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Ischemia modified albumin (IMA)
How many people
54 participants
Where
1 siteEgypt
Study dates
15 Jun 2018to 7 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Age more than 18 years old
  • Patients with isolated head injury

Who cannot join

  • 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
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

Egypt1 site

  • Kasr El Aini Hospital

    Cairo, 11562

Other trials in Egypt

About this study

Official title: 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.

Read the 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
Being tested
Ischemia modified albumin (IMA)
Keywords
Ischemia modified albumin, Traumatic brain injury, Troponin, Conscious Level, Poor outcome
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ischemia modified albumin (IMA)Diagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between IMA and mortality following TBI

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

    Measured: 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 (7)

  1. Correlation between 24 hours IMA and mortality following TBI

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

    Measured: 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

  2. The incidence of patients with elevated IMA

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

    Measured: IMA on admission to ICU and after 24 hours

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

    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.

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

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

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

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

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

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

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

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

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

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

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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start15 Jun 2018
  3. Primary completion7 Dec 2018
  4. Study completion7 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637101
Sponsor's protocol ID
N-23-2018
Status last verified
Jan 2019
First submitted
4 Aug 2018
Last updated
15 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nayak AR, Kashyap RS, Kabra D, Purohit HJ, Taori GM, Daginawala HF. Prognostic significance of ischemia-modified albumin in acute ischemic stroke patients: A preliminary study. Ann Neurosci. 2011 Jan;18(1):5-7. doi: 10.5214/ans.0972.7531.1118103.

    PubMed 25205910

  • Sbarouni E, Georgiadou P, Kremastinos DT, Voudris V. Ischemia modified albumin: is this marker of ischemia ready for prime time use? Hellenic J Cardiol. 2008 Jul-Aug;49(4):260-6. No abstract available.

    PubMed 18935713

  • Roy D, Quiles J, Gaze DC, Collinson P, Kaski JC, Baxter GF. Role of reactive oxygen species on the formation of the novel diagnostic marker ischaemia modified albumin. Heart. 2006 Jan;92(1):113-4. doi: 10.1136/hrt.2004.049643. No abstract available.

    PubMed 16365361

  • Chong ZZ, Li F, Maiese K. Oxidative stress in the brain: novel cellular targets that govern survival during neurodegenerative disease. Prog Neurobiol. 2005 Feb;75(3):207-46. doi: 10.1016/j.pneurobio.2005.02.004. Epub 2005 Apr 26.

    PubMed 15882775

  • Riera M, Llompart-Pou JA, Carrillo A, Blanco C. Head injury and inverted Takotsubo cardiomyopathy. J Trauma. 2010 Jan;68(1):E13-5. doi: 10.1097/TA.0b013e3181469d5b.

    PubMed 19065115

  • Prathep S, Sharma D, Hallman M, Joffe A, Krishnamoorthy V, Mackensen GB, Vavilala MS. Preliminary report on cardiac dysfunction after isolated traumatic brain injury. Crit Care Med. 2014 Jan;42(1):142-7. doi: 10.1097/CCM.0b013e318298a890.

    PubMed 23963125

  • 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.

    PubMed 27121183

  • Myburgh JA, Cooper DJ, Finfer SR, Venkatesh B, Jones D, Higgins A, Bishop N, Higlett T; Australasian Traumatic Brain Injury Study (ATBIS) Investigators for the Australian; New Zealand Intensive Care Society Clinical Trials Group. Epidemiology and 12-month outcomes from traumatic brain injury in australia and new zealand. J Trauma. 2008 Apr;64(4):854-62. doi: 10.1097/TA.0b013e3180340e77.

    PubMed 18404048

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Brain Injury, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03637101, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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