Combining Cerebrolysin and Amantadine for Traumatic Brain Injury Patients in ICU
The Impact and Outcomes of Combined Cerebrolysin and Amantadine Sulfate Administration on Management of Patients With Traumatic Brain Injury in the ICU
This study is testing if combining two medications, cerebrolysin and amantadine, can help improve recovery for adults with moderate to severe traumatic brain injuries in the ICU.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06052787 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of combining cerebrolysin and amantadine sulfate as an additional therapy for patients with moderate to severe traumatic brain injury (TBI) admitted to the ICU. The study will involve patients aged 18 to 70 years with a Glasgow coma scale score of 7-12 at admission. The goal is to measure potential improvements in neurological recovery and overall outcomes compared to standard management alone. The research is being conducted at Ain Shams University in Cairo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with moderate to severe TBI and a Glasgow coma scale score of 7-12 upon hospital admission.
Not a fit: Patients with a history of intracranial interventions, penetrating brain injuries, or severe renal impairment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could enhance recovery and improve outcomes for patients suffering from traumatic brain injuries.
How similar studies have performed: Previous studies have shown positive outcomes with amantadine in TBI patients, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 70 years. * Clinical diagnosis of head injury with moderate to severe TBI and a Glasgow coma scale (GCS) score of 7-12 at the time of hospital admission. * Pre-hospital intubation/sedation/paralysis was accepted if the GCS score had been assessed before intubation/sedation/paralysis by trained staff. Exclusion Criteria: * History of intracranial interventions as well as ischemic or hemorrhagic stroke. * Any neurological or non-neurological condition independent from TBI that might influence the functional outcome or other efficacy outcome measures. * Clear clinical signs of intoxication influencing the evaluation, in the investigator's judgment. * Patients with penetrating brain injury. * Pregnancy or lactation. * Patient with sever renal impairment (creatinine clearance \> 30 ml/ minute).
Where this trial is running
Cairo
- Faculty of medicine - Ain shams university — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Ragab D Elshabasy — faculty of medicine - Ain shams university
- Study coordinator: Ragab D Elshabasy
- Email: drrdr1@yahoo.com
- Phone: +201553726656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.