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

A Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin in Patients With Traumatic Brain Injury

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.

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