Back to resultsEffect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Memantine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
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.
Sites / Locations
- Faculty of medecine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control group (group 1)
Treatment group (group 2)
Arm Description
Patients in the control group (group 1) No memantine administration
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
Outcomes
Primary Outcome Measures
prognosis of moderate to sever head injury
Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05531383
Brief Title
Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
Official Title
Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
July 9, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group (group 1)
Arm Type
No Intervention
Arm Description
Patients in the control group (group 1) No memantine administration
Arm Title
Treatment group (group 2)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Memantine Hydrochloride
Other Intervention Name(s)
Namenda
Intervention Description
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.
Primary Outcome Measure Information:
Title
prognosis of moderate to sever head injury
Description
Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale
Time Frame
7days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim Talaat, MD
Organizational Affiliation
Minia University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of medecine
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Effect of Early Memantine Administration on Outcome of Patients With Moderate to Severe Traumatic Brain Injury
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