Critical appraisal of neuroprotection trials in head injury: what have we learned?
To date, despite very encouraging preclinical results, almost all phase II/III clinical neuroprotection trials in traumatic brain injury (TBI) have failed to show any consistent improvement in outcome for TBI patients. To understand the reasons behind such developments we need to review and evaluate the evolution of trial design as a result of our changing understanding of the pathophysiology of brain cell death and progress of translational research from the laboratory bench to the bedside. This paper attempts to critically appraise these neuroprotection trials, rationalize the paucity of effectiveness, review any recent developments in the field, and try to draw some conclusions on how to move forward.
Tolias
Christos M
CM
Division of Neurosurgery, Medical College of Virginia, Virginia Commonwealth University, Richmond, Virginia 23298-0631, USA.
Bullock
M Ross
MR
D000818:Animals; D002986:Clinical Trials as Topic; D006259:Craniocerebral Trauma / Q000188:drug therapy*; D006801:Humans; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D012107:Research Design
D018696:Neuroprotective Agents
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