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

NCT05531383 | Unknown

• 1 other identifier: 140-2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group (group 1)

NO INTERVENTION

Patients in the control group (group 1) No memantine administration

Treatment group (group 2)

ACTIVE COMPARATOR

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

Interventions

Memantine Hydrochloride DRUG

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.

Also known as: Namenda

Treatment group (group 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of medecine

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Memantine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ibrahim Talaat, MD

  Minia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: September 8, 2022
• Study Start: November 26, 2021
• Primary Completion: November 20, 2023
• Study Completion: July 9, 2024
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

EG (1)