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

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Amantadine; Cerebrolysin

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).