Ischemia Modified Albumin in Traumatic Brain Injury

NCT03637101 | Completed

• 1 other identifier: N-23-2018
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Ischemia modified albumin; Traumatic brain injury; Troponin; Conscious Level; Poor outcome

Outcome Measures

Primary Outcomes (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

  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)

• Correlation between 24 hours IMA and mortality following TBI

  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

  IMA on admission to ICU and after 24 hours

• The degree of correlation between severity of TBI and IMA

  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

  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

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

Interventions

Ischemia modified albumin (IMA) DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, 11562, Egypt

Location

Related Publications (8)

• 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.

  PMID: 25205910 BACKGROUND

• 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.

  PMID: 18935713 BACKGROUND

• 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.

  PMID: 16365361 BACKGROUND

• 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.

  PMID: 15882775 BACKGROUND

• 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.

  PMID: 19065115 BACKGROUND

• 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.

  PMID: 23963125 BACKGROUND

• 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.

  PMID: 27121183 BACKGROUND

• 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.

  PMID: 18404048 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, surgical intensive care and pain mangement

Study Record Dates

• First Submitted: August 4, 2018
• First Posted: August 17, 2018
• Study Start: June 15, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)