Status:
COMPLETED
Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU
Lead Sponsor:
Ain Shams University
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The goal of this interventional study is to Measure the potential benefits of combined administration of cerebrolysin and amantadine sulfate as an add-on therapy to the standard management of patients...
Detailed Description
Sixty-nine million individuals worldwide are estimated to sustain a TBI each year. The proportion of TBIs resulting from road traffic collisions was greatest in Africa and Southeast Asia (both 56%) an...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06052787
Start Date
September 1 2023
End Date
August 1 2025
Last Update
November 19 2025
Active Locations (1)
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1
Faculty of medicine - Ain shams university
Cairo, Egypt