Ischemia Modified Albumin in Traumatic Brain Injury

• ClinicalTrials.gov Identifier: NCT03637101
• Recruitment Status: Completed
• First Posted: August 17, 2018
• Last Update Posted: January 15, 2019
• Sponsor: Kasr El Aini Hospital
• Information provided by (Responsible Party): Rania Samir Fahmy, Kasr El Aini Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Traumatic Brain Injury	Diagnostic Test: Ischemia modified albumin (IMA)

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 Design

• Study Type: Observational
• Actual Enrollment: 54 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ischemia Modified Albumin as a Biomarker for Prediction of Poor Outcome in Patients With Traumatic Brain Injury. Observational Cohort Study
• Actual Study Start Date: June 15, 2018
• Actual Primary Completion Date: December 7, 2018
• Actual Study Completion Date: December 7, 2018

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

Egypt

Kasr El Aini Hospital

Cairo, Egypt, 11562

Sponsors and Collaborators

Kasr El Aini Hospital

More Information

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Rania Samir Fahmy, Lecturer of Anesthesia, surgical intensive care and pain mangement, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT03637101
• Other Study ID Numbers: N-23-2018
• First Posted: August 17, 2018
• Last Update Posted: January 15, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rania Samir Fahmy, Kasr El Aini Hospital:

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

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Ischemia; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Pathologic Processes