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NCT05531383 Clinical Trial

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

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05531383
Other study ID # 140-2021
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 26, 2021
Est. completion date July 9, 2024

Study information
Verified date September 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of Early Memantine Administration on Outcome of Participents with Moderate to Severe Traumatic Brain Injury

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date July 9, 2024
Est. primary completion date November 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Memantine Hydrochloride
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.

Locations
Country Name City State
Egypt Faculty of medecine Minya Minia

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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