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

Not Applicable

Active, not recruiting

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Memantine Hydrochloride

• Registration Number: NCT05531383
• Lead Sponsor: Minia University

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.

Study Timeline

• Study Start: 2021-11-26
• Study First Submitted: 2022-03-08
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-03
• Last Update Submitted: 2022-09-03
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08
• Primary Completion: 2023-11-20
• Study Completion: 2024-07-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group (group 2)	Memantine Hydrochloride	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

Primary Outcome Measures

Name	Time	Method
prognosis of moderate to sever head injury	7days	Evaluating the effect of memantine administration on the conscious level of patients using the Glasgow coma scale

Trial Locations

Locations (1)

Faculty of medecine; 🇪🇬 Minya, Minia, Egypt