- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531383
Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minia
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Minya, Minia, Egypt, 61111
- Faculty of medecine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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NO_INTERVENTION: Control group (group 1)
Patients in the control group (group 1) No memantine administration
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ACTIVE_COMPARATOR: Treatment group (group 2)
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
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prognosis of moderate to sever head injury
Time Frame: 7days
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Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale
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7days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ibrahim Talaat, MD, Minia University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- 140-2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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