Clinical trial NCT04527289: Impact of Amantadine on Traumatic Brain Injury
Official title: Potential Impact of Amantadine on Traumatic Brain Injury Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trauma, Brain
Keywords: traumatic brain injury (TBI)
Interleukin-18 (IL-18)
Neuron specific enolase (NSE)
Neurotensin (NT)
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 At the end of 6 weeks, prognosis biomarkers will be withdrawn.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.

Eligibility 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

Primary outcomes:
measure: Neurotensin pg/ml
timeFrame: 2 weeks
measure: Neuron specific enolase (NSE) ng/mL
timeFrame: 2 Weeks
measure: interleukin-18 (IL-18) pg/ml
timeFrame: 2 Weeks
measure: ICU stay (days)
timeFrame: 6 weeks
Secondary outcomes:
measure: (GCS) Total Glasgow Coma Scale score: (Severe: GCS 8 or less- Moderate: GCS 9-12- Mild: GCS 13-15).
timeFrame: 6 weeks
measure: GCS-E
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Elgarbia
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Lecturer
role: STUDY_DIRECTOR
References:
citation: Stelmaschuk S, Will MC, Meyers T. Amantadine to Treat Cognitive Dysfunction in Moderate to Severe Traumatic Brain Injury. J Trauma Nurs. 2015 Jul-Aug;22(4):194-203; quiz E1-2. doi: 10.1097/JTN.0000000000000138.
citation: Bharosay A, Bharosay VV, Varma M, Saxena K, Sodani A, Saxena R. Correlation of Brain Biomarker Neuron Specific Enolase (NSE) with Degree of Disability and Neurological Worsening in Cerebrovascular Stroke. Indian J Clin Biochem. 2012 Apr;27(2):186-90. doi: 10.1007/s12291-011-0172-9. Epub 2011 Nov 8.
citation: Ciaramella A, Della Vedova C, Salani F, Viganotti M, D'Ippolito M, Caltagirone C, Formisano R, Sabatini U, Bossu P. Increased levels of serum IL-18 are associated with the long-term outcome of severe traumatic brain injury. Neuroimmunomodulation. 2014;21(1):8-12. doi: 10.1159/000354764. Epub 2013 Sep 26.