Traumatic Brain Injury
Conditions
Brief summary
The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on therapy to standard care in patients with acute traumatic brain injury (TBI). The study duration for each patient is 180 days.
Interventions
DRUGCerebrolysin
IV infusion, 50 ml/day, 10 days (treatment cycle will be repeated one and two months later if patient has a score of less than 7 in the extended Glasgow Outcome Scale on Day 30)
DRUG0.9% NaCl, saline
IV infusion, 50 ml/day, 10 days (treatment cycle will be repeated one and two months later if patient has a score of less than 7 in the extended Glasgow Outcome Scale on Day 30)
Sponsors
Ever Neuro Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of TBI and a GCS 7-12 * Only isolated TBI * CT * Pre-Trauma Karnofsky-Index = 100 * Age 18-60 years * Male and female patients * Time to needle for study medication within 6 hours after injury * Patient is not pregnant or lactating during the trial and is not of childbearing potential * Patient was able to speak, read and write in a pre-defined study language before the accident. * Reasonable expectation of completion of outcome measures at follow-up * Written informed consent
Exclusion criteria
* Evidence of pre-existing major health problems * Any neurological or non-neurological condition independent from TBI that might influence the functional outcome or other efficacy outcome measures * Injury of writing hand influencing cognitive or other outcome measures * Clear clinical signs of intoxication influencing the evaluation * Major drug dependency including alcohol * Chronic treatment with steroids, Ca2+-channel blockers or major anticoagulants * Penetrating high-velocity missile head trauma * Stab wound trauma into the brain * Patients with spinal cord injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of mean score in MMSE, PSI, Stroop Color-Word Test, Early Reha BI, GOS-E | Day 10 | Global status is assessed by an ensemble of appropriate, single efficacy criteria to be tested by a multivariate, directional test approach |
| Composite endpoint of mean score in PSI, Stroop Color-Word Test, Color Trails Test, Digit Span, Early Reha BI, Finger Tapping Test, MMSE, Hospital Anxiety and Depression Scale, GOS-E | Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality | Day 10 |
| Composite endpoint of mean score in PSI, Stroop Color-Word Test, Color Trails Test, Digit Span, Early Reha BI, Finger Tapping Test, MMSE, Hospital Anxiety and Depression Scale, GOS-E | Day 180 |
Countries
Hong Kong
Outcome results
None listed