Impact of Amantadine on Traumatic Brain Injury

  • STATUS
    Recruiting
  • days left to enroll
    69
  • participants needed
    50
  • sponsor
    Damanhour University
Updated on 1 February 2021

Summary

The aim of this study is to evaluate whether the addition of amantadine to the management regimen of traumatic brain injury patients would have a favorable effect on recovery and neurological complications in association with prognosis biomarkers Interleukin-18 (IL-18), Neuron-specific enolase (NSE) and (Neurotensin).

Description

Proposal Steps

  1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
  2. All participants agreed to take part in this clinical study and provide informed consent.
  3. Patients will be enrolled if they present with clinical signs of trauma, from Emergency department at Tanta University Hospital
  4. Complete physical, laboratory, radiological assessment will be done for all patients
  5. Serum samples will be collected for measuring the biomarkers.
  6. All enrolled 50 patients will be divided into two groups; Group I are patients who will receive amantadine as added on therapy. Group II are patients who will be managed with the standard regimen.
  7. All patients will be followed up during 6 weeks period.
  8. At the end of 6 weeks, prognosis biomarkers will be withdrawn.
  9. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  10. Measuring outcome: The primary outcome is to compare the effect of adding amantadine on recovery rate and neurological complications in trauma patients.
  11. Results, conclusion, discussion and recommendations will be given.

Methodology

  • 50 Patients will be randomized equally to the assigned study groups
  • Prognosis biomarkers (IL-18, NSE and Neurotensin) will be measured using ELISA
  • Conventional routine tests (including renal function tests) will be assessed
  • Patients will be evaluated clinically (such as Glasgow score) for recovery rate for neurological complications.

Details
Condition Brain Injury
Treatment Placebo, Amantadine (100mg) as add on therapy.
Clinical Study IdentifierNCT04527289
SponsorDamanhour University
Last Modified on1 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients will be enrolled if they present with clinical signs of trauma
brain injury

Exclusion Criteria

Age lower than 18
Females with positive pregnancy test
Known congestive heart failure or ischemic heart disease
Any injury disturbs the examination (high cervical cord injury or locked-in syndrome, could be a source of bias)
Penetrating head trauma
Need for any operation (laparotomy or craniotomy)
Severe brain disease (For example CVA history or brain tumour)
Renal failure with GFR lower than 60 ml/min
Patients with unknown identity
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