Ischemia Modified Albumin in Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637101
• Other study ID #: N-23-2018
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: December 7, 2018

Study information

• Verified date: January 2019
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 7, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Ischemia
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• Ischemia modified albumin (IMA)
Ischemia modified albumin is a biomarker for cardiac ischemia and acute stroke whether ischemic or hemorrhagic

Locations

Country	Name	City	State
Egypt	Kasr El Aini Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. Epub 2005 Apr 26. Review. — View Citation

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. Erratum in: Scand J Trauma Resusc Emerg Med. 2016;24:79. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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.	IMA on admission to ICU and after 24 hours
Secondary	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.	Glasgow coma scale immediately on admission to the ICU, IMA will be collected on admission to ICU and after 24 hours
Secondary	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)	The number of days in ICU till discharge or mortality up to 28 days post admission
Secondary	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)	The number of days in ICU till discharge or mortality up to 28 days post admission
Secondary	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)	The number of days in ICU till discharge or mortality up to 28 days post admission
Secondary	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	Glasgow coma scale immediately on admission to the ICU and daily till mortality or discharge up to 28 days post admission