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The CAPTAIN’s Tale - The story of an unbelievable TBI Trial

Christian Matula

Neurosurgical Department, Medical University of Vienna, Austria

Traumatic Brain Injury (TBI) is an undisputed and fundamental problem worldwide. The majority of TBI trials failed and ended up mostly as a nightmare. Cerebrolysin as a pharmacological agent has created over the time a light at the horizon. This presentation tells the story of the Captain-Trial with all its ups and downs from its beginnings to to newly designed clinical research we have achieved until today. The story of an unbelievable TBI trial, trying to make the impossible possible, opening the door widely to new styled TBI trials.

As all good tales, it starts with a “Once upon a time”. In the 50/60ies TBI was seen as a pure surgical disease. Craniotomy for evacuation of hematomas was the only modality available for the reduction of intracranial pressure (ICP). Nowadays, after an explosion of new insights in TBI research has driven this paradigm shift on the physiology of healthy and injured brains. Today it is clearly seen as a cyto-pathological disease! Neurotrophic factors are the most important endogenous molecules involved in brain protection and recovery and they can switch DNA programs. Cerebrolysin is the only drug available on the market for clinical use containing active fragments of some important neurotrophic factors.

The Captain trial (Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery) is a randomized, double-blind, placebo-controlled trial to investigate safety and efficacy of Cerebrolysin in patients with traumatic brain injury. The trial was designed to investigate the clinical effects of Cerebrolysin in the acute phase (neuroprotective strategy) as well as during the phases of early, long-term and overall recovery (neurorestorative strategy).

The CAPTAIN trial has been the first TBI trial with a ‘‘true’’ multidimensional approach based on full outcome scales while avoiding previous weaknesses, such as loss of information through ‘dichotomization’, unrealistic assumptions such as ‘‘normal distribution,’’ or bias by insensitivity to outcome clusters. Within the global outcome analysis, the cognitive assessments demonstrated highly significant results and may be a door opener for future guideline inclusions. Global Outcome in particular, Captain Cognition Scales could be proven to be particularly highly significant and the results served as a „door opener“ for all future guideline inclusions!

We are currently living in a very depressive time and age; post-treatment depression is a previously neglected problem, even in various cerebrovascular emergencies! For most of the specialists in Neurosurgery, but also Neurology not so much in the foreground, but a real problem for the patient himself.

Today we can say, that the results from the Captain study significantly helped to optimize treatment concepts in any kind of cerebrovascular emergency based on a multidisciplinary team approach.