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

M

Minia University

Status

Active, not recruiting

Conditions

Traumatic Brain Injury

Treatments

Drug: Memantine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT05531383
140-2021

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Control group (group 1)
No Intervention group
Description:
Patients in the control group (group 1) No memantine administration
Treatment group (group 2)
Active Comparator group
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
Treatment:
Drug: Memantine Hydrochloride

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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