PMID: 15335108Sep 1, 2004Paper

Lessons from epidemiologic studies in clinical trials of traumatic brain injury

Acta Neurochirurgica. Supplement
A Farin, L F Marshall

Abstract

Lessions from epidemiological studies. The Clinical Trial Group for Neurosurgery of the University of California San Diego (UCSD) is involved in epidemiological studies and trials of new pharmacological agents in traumatic brain injury. A great number (> 10,000) of patients has been prospectively analyzed forming an integrated database for further purposes. The development of these databases is based on earlier work by the European Neurosurgeons Jennett and Braakmann and the US-Traumatic Coma Data Bank Study. These studies allowed for the development of sophisticated data collection instruments which were used in the international Tirilizad Trials which enrolled over 1,100 patients. A major observation from that trial was that pretreatment hypotension or hypoxia could be unbalanced even in a large two arm blinded study. Another issue of the tirilazad trial was the influence of gender affecting not only outcome but also drug metabolism. Similar experiences were gathered with the phase-III trial on the competitive NMDA-receptor antagonist selfotel, which interferes with the excitotoxic amino acid glutamate as mediator of secondary brain damage, as ischemia-induced neuronal degeneration. Unfortunately, the trial, already underway,...Continue Reading

Citations

Nov 27, 2009·Journal of Neurotrauma·Jeffrey J BazarianMichael P McDermott
Sep 29, 2012·Journal of Neurotrauma·Ishita SiddiqAndrew J Baker
Jun 16, 2006·Journal of Neurotrauma·Chlodwig KirchhoffPeter Biberthaler
Jul 5, 2013·Journal of Neurotrauma·Bernhard WalderJoseph Osterwalder
Mar 1, 2006·Journal of Neurotrauma·Daniel P DavisDavid B Hoyt
Sep 22, 2012·Journal of Neurotrauma·David W NelsonBo-Michael Bellander
Sep 25, 2016·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Chiara S HallerEllen J Langer

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