The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery

• Cerebrolysin (Drug), also known as Cognicer, Renacenz: 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)
• 0.9% NaCl, saline (Drug), also known as 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)

Primary outcomes

• 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]
• 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 90]

Secondary outcomes

• Mortality [Day 10]
• Mortality [Day 30]
• Mortality [Day 90]
• 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]
• Mortality [Day 180]

Sex: All, ages: 18 Years to 60 Years

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

• Results publication: Poon W, Matula C, Vos PE, Muresanu DF, von Steinbuchel N, von Wild K, Homberg V, Wang E, Lee TMC, Strilciuc S, Vester JC. Safety and efficacy of Cerebrolysin in acute brain injury and neurorecovery: CAPTAIN I-a randomized, placebo-controlled, double-blind, Asian-Pacific trial. Neurol Sci. 2020 Feb;41(2):281-293. doi: 10.1007/s10072-019-04053-5. Epub 2019 Sep 7. PMID 31494820

• Wai S Poon, Prof., Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong