Intracranial injuries with associated fractures. Intracranial injury
Conditions
Interventions
Intervention 1: Intervention group: Among patients admitted to the hospital within 24 hours of the incident who met the inclusion criteria, 20 patients will be allocated, using a block randomization m
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adults aged 18–75 years Patients with a Glasgow Coma Scale (GCS) score of 5 to 12 within the first 24 hours after traumatic brain injury who did not require craniotomy following hospital admission Patients without any life-threatening disease prior to the head injury; however, those with chronic medical conditions may be included at the discretion of the investigators Patients able to receive medication via nasogastric (NG) tube or orally, with no contraindication to enteral administration Patients with traumatic brain injury admitted to Imam Khomeini Hospital in Sari who meet the inclusion criteria, and from whom informed consent has been obtained either directly or from their legal guardian or representative
Exclusion criteria
Exclusion criteria: Patients treated with alteplase within the past three months. Patients with a history of acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) who are currently receiving dual antiplatelet therapy (DAPT) with aspirin plus ticagrelor or clopidogrel. Patients with conditions that impair gastrointestinal absorption, such as uncontrolled nausea or diarrhea; sepsis requiring vasopressor support (dopamine >10 µg/kg/min, epinephrine >0.3 µg/kg/min, or norepinephrine >0.1 µg/kg/min); or active phases of colitis or Crohn’s disease. Patients with a history of allergy or intolerance to fish liver oil or its derivatives. Patients with a platelet count below 50,000/µL. Patients with a history of gastrointestinal bleeding due to peptic ulcer within the past 21 days. Pregnancy Presence of cancer or brain tumor that, in the opinion of the investigators, could interfere with treatment assessment. Patients with multiple traumatic injuries (e.g., thoracic, abdominal, etc.) that may compromise treatment evaluation according to the investigators’ judgment. Penetrating head injury History of severe traumatic brain injury (TBI) or any prior brain injury resulting in permanent neurological disability before enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be measured based on the rate of change in the level of consciousness to assess neurological outcomes after eicosapentaenoic acid administration. Timepoint: on days 0 (admission day), 3, 7, and at discharge. Method of measurement: Glasgow Coma Scale score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the duration of need for mechanical ventilation. Timepoint: Days under mechanical ventilation. Method of measurement: Day.;Evaluation and comparison of 30-day mortality rates of patients between the two groups of patients. Timepoint: 30-day mortality. Method of measurement: Day.;Measurement and comparison of nutritional status and the need for nutritional support in patients. Timepoint: On the first and seventh days of hospitalization. Method of measurement: Modified Nutrition Risk in Critically Ill (mNUTRIC) Score.;Measurement and comparison of respiratory function in patients receiving mechanical ventilation. Timepoint: Endotracheal tube status will be assessed on days 0 (admission), 3, 7, and at discharge between the two groups, in patients receiving mechanical ventilation. Method of measurement: PaO2/FiO2 ratio.;To predict disease severity and mortality among hospitalized patients. Timepoint: on day 1 of intensive care unit (ICU) admission. Method of measurement: APACHE II (Acute Physiology And Chronic Health Evaluation) score.;Measuring the severity of the inflammatory response. Timepoint: On the first and seventh days of hospitalization. Method of measurement: Based on serum C-reactive protein level.;Assessment and follow-up of the severity of organ failure and hemodynamic failure in patients admitted to the ICU. Timepoint: On the first and seventh days of hospitalization. Method of measurement: Sequential Organ Failure Assessment (SOFA) Score.;Assessing and comparing patients' functional status. Timepoint: Day of discharge and 3 months after discharge. Method of measurement: Glasgow Outcome Scale score.;Measuring and comparing the length of stay of patients in the neurology and intensive care unit. Timepoint: Days of hospitalization. Method of measurement: Day. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShahram Ala
Mazandaran University of Medical Sciences
Outcome results
None listed