Trauma, Brain
Conditions
Keywords
traumatic brain injury (TBI), Interleukin-18 (IL-18), Neuron specific enolase (NSE), Neurotensin (NT)
Brief 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).
Detailed 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 At the end of 6 weeks, prognosis biomarkers will be withdrawn. 9.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.
Interventions
Amantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube
DRUGPlacebo
patients will be managed with placebo as add on to the standard regimen.
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind
Intervention model description
All enrolled 50 patients will be divided into two groups; Group I are patients who will receive amantadine as add on therapy. Group II are patients who will be managed with the standard regimen.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurotensin pg/ml | 2 weeks | Neurotensin pg/ml by ELISA Kit |
| Neuron specific enolase (NSE) ng/mL | 2 Weeks | Neuron specific enolase (NSE) by ELISA Kit |
| interleukin-18 (IL-18) pg/ml | 2 Weeks | interleukin-18 (IL-18) by ELISA Kit |
| ICU stay (days) | 6 weeks | ICU stay (days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15). | 6 weeks | number of GCS to describe the level of consciousness in a person following a traumatic brain injury. |
| GCS-E | 6 months | The Glasgow Outcome Scale-Extended (GOS-E) |
Countries
Egypt
Outcome results
None listed