CompletedPhase 3

Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU

Egypt150 participantsStarted 2023-09-01

Plain-language 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 admitted to the ICU with traumatic brain injury.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

The Glasgow Coma Scale (GCS)

Timeframe: Glasgow coma scale (GCS) will be recorded on admission, and every week up to 6 weeks of trauma to detect the improvement in level of consciousness after management in all groups.

Disability rating-scale for severe head trauma (DRS)

Timeframe: DRS score will be collected at baseline and weekly through week 6 (during 4 weeks of treatment and 2 weeks after discontinuation).

Coma Recovery Scale-Revised (CRS-R)

Timeframe: CRS-R will be compared over the 4 weeks of treatment and during 2-weeks after discontinuation of treatment

The Glasgow Outcome Scale (GOS)

Timeframe: atients in all groups will be assessed with The Glasgow Outcome Scale (GOS) on the end of 6th week.

Trial details

NCT IDNCT06052787

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

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