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Trial record 28 of 315 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Ischemia Modified Albumin in Traumatic Brain Injury

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

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 will be admitted with TBI, blood samples will be taken once written informed consent obtained. Initial evaluation on admission will be 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) will be 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 will be done.

CT scan will be performed in all the cases for the confirmation of TBI. Glasgow coma scale (GCS) will be assessed on admission and recorded and assessed daily to evaluate prognosis. Patients will be monitored by BP, ECG, and Pulse oximetry. All patients will receive standard medical treatment which include 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 will be placed in plain tubes containing separation gels and allowed to clot for 30 min. They will be centrifuged before separating the serum. Samples will immediately frozen and stored at -80°C for the IMA.

IMA will be measured using ELISA technique. 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 will be measured and will be recorded at time of admission and every 2 hours for 24 hours
    • Length of ICU stay
    • 28-day mortality
    • Troponin I level on admission and 24 hours after admission
    • GCS at admission and daily till mortality or discharge

Study Type : Observational
Estimated 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
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine



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


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 incidence of patients with elevated both IMA and troponin levels [ Time Frame: IMA and troponin will be collected on admission to ICU and after 24 hours ]
    The percentage of patients having increased levels of IMA in ng/ml and troponin in ng/ml upon admission to ICU and 24 hours later

  4. The degree of correlation between TBI and conscious level (severity of traumatic brain injury) and troponin levels. [ Time Frame: Glasgow coma scale immediately on admission to the ICU, troponin will be collected on admission to ICU and after 24 hours ]
    The severity of traumatic brain injury classified by Glasgow Coma Scale as mild 13-25, moderate 9-12 or severe 3-8 and the troponin levels in ng/ml in those patients.

  5. 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 13-25, moderate 9-12 or severe 3-8 and the IMA levels in ng/ml in those patients.

  6. 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)

  7. 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)

  8. 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)

  9. 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



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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 will be 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637101


Contacts
Contact: Rania S Fahmy 01222651063 ransam98@gmail.com
Contact: Mohamed F El Emady 01001450053 mohamed.farid@hotmail.com

Locations
Egypt
Kasr El Aini Hospital Recruiting
Cairo, Egypt, 11562
Contact: Rania S Fahmy, PHD    +201222651063    ransam98@gmail.com   
Contact: Mohamed F El Emady, PHD    +201001450053    mohamed.farid@hotmail.com   
Principal Investigator: Tarek A Radwan, Professor         
Principal Investigator: Rania S Fahmy, PHD         
Principal Investigator: Mohamed F El Emady, PHD         
Principal Investigator: Ahmed S Khedr         
Principal Investigator: Badawy M El kholy, Professor         
Principal Investigator: Mohamed A Mohamed, Assistant Professor         
Sponsors and Collaborators
Kasr El Aini Hospital

Publications:

Responsible Party: Rania Samir Fahmy, Lecturer of Anesthesia, surgical intensive care and pain mangement, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03637101     History of Changes
Other Study ID Numbers: N-23-2018
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
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:
Wounds and Injuries
Brain Injuries
Ischemia
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pathologic Processes