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

Status

Completed

Phase

Phase 3

Enrollment

150 participants (actual)

Sponsor

Ain Shams University · Other

Design

Randomized · Quadruple masking

Countries

1 country

Egypt

Start

1 Sept 2023

Primary completion

30 May 2025

Completion

1 Aug 2025

First posted

25 Sept 2023

Last update posted

19 Nov 2025

Conditions

Traumatic Brain Injury

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.

• No intervention

  standard of care

  patients receiving the standard protocol of management of head injury in the ICU including * Ventilatory support, sedation and analgesia. * Hemodynamic support. * Hyperosmolar therapy. * Early post traumatic seizure prophylaxis. * Nutritional support: will try to start enteral feeds as soon as possible or total parenteral * nutrition will be used in the case of enteral feeding intolerance. * Temperature management: to maintain normothermia * Glycemic control: to maintain a glucose level of \[140 -180 mg/dl\] * Peptic ulcer prophylaxis: * Deep venous thrombosis (DVT) prophylaxis

• Experimental

  standard of care + Cerebrolysin

  patients receiving the standard protocol of management of head injury in the ICU plus 2 cycles of Cerebrolysin , each cycle 10 days, for total 20 days. From day 1 to day 10: cerebrolysin 50 ml once daily diluted in 250 ml normal saline intravenous infusion over 15 minutes. From day 21-30 : cerebrolysin 20 ml once daily diluted in 250 ml normal saline intravenous infusion over 15 minutes.

• Experimental

  standard of care + Cerebrolysin + Amantadine sulfate

  patients receiving the standard protocol of management of head injury in the ICU plus amantadine sulfate at a dose of 100 mg twice daily on the day after randomization, with this dose will be continued for 14 days. The dose will be increased to 150 mg twice daily at week 3 and to 200 mg twice daily at week 4 (total 4 weeks), combined with 2 cycles of Cerebrolysin , each cycle 10 days, for total 20 days. From day 1 to day 10: cerebrolysin 50 ml once daily diluted in 250 ml normal saline intravenous infusion over 15 minutes. From day 21-30 : cerebrolysin 20 ml once daily diluted in 250 ml normal saline intravenous infusion over 15 minutes.

1. The Glasgow Coma Scale (GCS)

   Time frame · 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.

   Registry description

   The Glasgow Coma Scale (GCS) is used to assess the level of consciousness. It depends on the best motor, verbal and eye opening responses. GCS is used to classify insult severity as minor \[GCS 13-15\], moderate \[GCS 9-12\] and severe \[GCS 3-8\].

2. Disability rating-scale for severe head trauma (DRS)

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

   Registry description

   Disability rating-scale for severe head trauma (DRS) includes measures of arousability, awareness and responsivity of eye opening, verbalization, and motor response; cognitive ability of for Self Care Activities: understanding of feeding, dressing, and grooming; degree of assistance and supervision required; and employability. Scores range from 0 to 29, with higher values indicating greater disability.

3. Coma Recovery Scale-Revised (CRS-R)

   Time frame · CRS-R will be compared over the 4 weeks of treatment and during 2-weeks after discontinuation of treatment

   Registry description

   Coma Recovery Scale-Revised (CRS-R) is a standardized neurobehavioral assessment tool comprising six organized subscales (i.e., auditory, visual, motor, oro-motor,verbal, communication, and arousal); scores range from 0 to 23, with higher scores indicating a higher level of neurobehavioral function.

4. The Glasgow Outcome Scale (GOS)

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

   Registry description

   The Glasgow Outcome Scale (GOS) is one of the most widely used outcome instruments to assess global disability and recovery after traumatic brain injury. Patients in all groups will be assessed with The Glasgow Outcome Scale (GOS) on the end of 6th week which classify patients into: dead, vegetative state, severe disability, moderate disability and good recovery.