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

NCT ID: NCT05531383

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-26

Study Completion Date

2024-07-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group (group 1)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Memantine Hydrochloride

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Namenda

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Shady Nemr Youssef

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ibrahim Talaat, MD

Role: STUDY_CHAIR

Minia University

Locations

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Faculty of medecine

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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140-2021

Identifier Type: -

Identifier Source: org_study_id

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