Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury

Study Overview
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Brief Summary
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Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury

Detailed Description
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Studying the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) & serum NSE levels in participents with moderate to severe TBI as well as outcome. Investigators evaluate prognostic effect of memantine on participents with moderate to severe TBI. also to estimate which of platelet, platelet/lymphocyte ratio (PLR), C reactive protein (CRP) or serum NSE levels will be affected by administration of memantine in participents with moderate to severe TBI as a predictor of outcome.

Official Title
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Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: Memantine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe closed TBI with initial GCS of 4-12 Age from 18 to 65 years of both sexes Able to tolerate enteral feeding and drug administration within the first 24 hours of TBI. Exclusion Criteria: Open TBI or patients who would need open craniotomy later on. Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours, acute or chronic renal insufficiency, hepatic diseases, autoimmune abnormalities, history of epileptic fits and known malignancies. Patients with chest, cardiac, abdominal trauma or any other trauma requiring mechanical ventilation. Patients with body mass index (BMI) <18.5 or > 34.9 kg/m2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group (group 1)<br>Patients in the control group (group 1) No memantine administration | |
| Active Comparator: Treatment group (group 2)<br>in addition to the standard treatment, they will receive memantine (30 mg) twice daily, either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital. The memantine dose administered in our study was based on the maximum dose of 60 mg/day reported in prior human studies | Drug: Memantine Hydrochloride<br>* study the effect of memantine on platelet, platelet/lymphocyte ratio (PLR) and C reactive protein (CRP) & serum NSE levels in patients with moderate to severe TBI as well as their outcome.<br>* Other names: Namenda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis of moderate to sever head injury | Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale | 7days |