title: Cerebrolysin Asian Pacific trial in acute brain injury and neurorecovery: design and methods.
abstract: Traumatic brain injury (TBI) is one of the leading causes of injury-related death. In the United States alone, an estimated 1.7 million people sustain a TBI each year, and approximately 5.3 million people live with a TBI-related disability. The direct medical costs and indirect costs such as lost productivity of TBIs totaled an estimated $76.5 billion in the U.S. in the year 2000. Improving the limited treatment options for this condition remains challenging. However, recent reports from interdisciplinary working groups (consisting primarily of neurologists, neurosurgeons, neuropsychologists, and biostatisticians) have stated that to improve TBI treatment, important methodological lessons from the past must be taken into account in future clinical research. An evaluation of the neuroprotection intervention studies conducted over the last 30 years has indicated that a limited understanding of the underlying biological concepts and methodological design flaws are the major reasons for the failure of pharmacological agents to demonstrate efficacy. Cerebrolysin is a parenterally-administered neuro-peptide preparation that acts in a manner similar to endogenous neurotrophic factors. Cerebrolysin has a favorable adverse effect profile, and several meta-analyses have suggested that Cerebrolysin is beneficial as a dementia treatment. CAPTAIN is a randomized, double-blind, placebo-controlled, multi-center, multinational trial of the effects of Cerebrolysin on neuroprotection and neurorecovery after TBI using a multidimensional ensemble of outcome scales. The CAPTAIN trial will be the first TBI trial with a 'true' multidimensional approach based on full outcome scales, while avoiding prior weaknesses, such as loss of information through "dichotomization," or unrealistic assumptions such as "normal distribution."
authors.affiliation: 1 Division of Neurosurgery, Prince of Wales Hospital, the Chinese University of Hong Kong , Hong Kong, China .
authors.forename: Wai
authors.initials: W
authors.lastname: Poon
authors.forename: Pieter
authors.initials: P
authors.lastname: Vos
authors.forename: Dafin
authors.initials: D
authors.lastname: Muresanu
authors.forename: Johannes
authors.initials: J
authors.lastname: Vester
authors.forename: Klaus
authors.initials: K
authors.lastname: von Wild
authors.forename: Volker
authors.initials: V
authors.lastname: Hömberg
authors.forename: Ernest
authors.initials: E
authors.lastname: Wang
authors.forename: Tatia M C
authors.initials: TM
authors.lastname: Lee
authors.forename: Christian
authors.initials: C
authors.lastname: Matula
mesh_terms: D000328:Adult; D000368:Aged; D000596:Amino Acids / Q000008:administration & dosage / Q000494:pharmacology*; D001210:Asia, Southeastern; D001930:Brain Injuries / Q000188:drug therapy*; D002681:China; D004311:Double-Blind Method; D005202:Asia, Eastern; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000494:pharmacology*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D020127:Recovery of Function / Q000187:drug effects*; D012107:Research Design
chemical_list: D000596:Amino Acids; D018696:Neuroprotective Agents; C006952:cerebrolysin
keywords: Cerebrolysin; multidimensional; neuroprotection; recovery; traumatic brain injury