Clinical Trials in Traumatic Brain Injury: Lessons for the Future

Journal of Neurosurgical Anesthesiology

Volumn 16, Issue 1, 2004, Pages 87-94

  Doppenberg, Egon M R ^a   Choi, Sung C ^a   Bullock, Ross ^a  

^a VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical; Neuroprotective; Pitfalls; Trials

Indexed keywords

4 AMINOPYRIDINE; 4 PHOSPHONOMETHYLPIPECOLIC ACID; 6,7 DICHLORO 5 NITRO 2,3 QUINOXALINEDIONE; APTIGANEL; BARBITURIC ACID DERIVATIVE; BAY 387271; BAY 442041; CORTICOSTEROID; CYCLOSPORIN; DEXANABINOL; DIZOCILPINE; EAA 494; ELIPRODIL; FAMPRIDINE SR; IMMUNOPHILIN; LANICEMINE; LETEPRINIM; MANNITOL; NERAMEXANE; NEUROPROTECTIVE AGENT; NIMODIPINE; NS 1209; PENTOBARBITAL; REPINOTAN; S 1746; SCAVENGER; SCOPOLAMINE; SIPATRIGINE; SUPEROXIDE DISMUTASE; TIRILAZAD; TRAXOPRODIL; TRIAMCINOLONE; TROMETAMOL; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ADOPTIVE IMMUNOTHERAPY; ANIMAL MODEL; AXONAL INJURY; BRAIN BLOOD FLOW; BRAIN INJURY; BRAIN ISCHEMIA; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONFERENCE PAPER; DRUG PENETRATION; DRUG SAFETY; DRUG TOLERABILITY; HISTOPATHOLOGY; HUMAN; HYPOTENSION; HYPOTHERMIA; NEUROPATHOLOGY; NEUROPROTECTION; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; PATHOPHYSIOLOGY; PRIORITY JOURNAL; STEM CELL TRANSPLANTATION; T LYMPHOCYTE;

ANIMALS; BRAIN INJURIES; CLINICAL TRIALS; DISEASE MODELS, ANIMAL; HUMANS; NEUROPROTECTIVE AGENTS;

EID: 0347593988     PISSN: 08984921     EISSN: None     Source Type: Journal    
DOI: 10.1097/00008506-200401000-00019     Document Type: Conference Paper

References (32)

1. Mclellan DR, Adams JH, Graham DI. 1986. The structural basis of the vegetative state and prolonged coma after non-missile injury. In: Papo, I., Cohadon, F., Massarotti, M. (Eds.) Le Coma Traumatique. Padova: Liviana Editrice, 1986:165.
2. Povlishock JT, Becker DP, Cheng CLY, et al. Axonal change in minor head injuries. J Neuropathol Exp Neurol. 1983;42:225-242.
3. Pettus EH, Christman CW, Giebel ML, et al. Traumatically induced altered permeability: Its relationship to traumatically induced reactive axonal change. J Neurotrauma. 1994;11:507-522.
4. Graham DI. 1985. The pathology of brain ischemia and possibilities for therapeutical intervention. Br J of Anesth. 57:3-25.
5. Adams JH, Graham DI, Genarelli TA. Head injury in man and experimental animals: neuropathology. Acta Neurochir. 1983;32:S15-S30.
6. Bouma GJ, Muizelaar JP, Stringer WA, et al. Ultra-early evaluation of regional cerebral blood flow in severely head-injured patients using xenon-enhanced computerized tomography. J Neurosurg. 1992;77:360-368.
7. Schroder, ML, Muizelaar, JP, Bullock, R., et al. 1994. Focal ischemia due to traumatic contusion documented by stable Xenon CT and ultrastructural studies. J Neurosurg. 82:966-971.
8. Astrup, J Siesjo PK, Symon L. 1981: thresholds in cerebral ischemia - the ischemic penumbra. Stroke 12:723-725.
9. Branston NM, Symon L, Crockard HA, et al. Relationships between the cortical evoked potential and local cortical blood flow following acute middle cerebral artery occlusion. Exp Neurol. 1974;45:195-208.
10. Jones TH, Morawetz RB, Crowell RM, et al. Threshold of focal ischemia in awake monkeys. J Neurosurg. 1981;54:773-782.
11. Kuroda Y, Bullock R. Failure of cerebral blood flow - metabolism coupling after acute subdural hematoma in the rat. Neurosurgery. 1992;31: 1062-1071.
12. Schroder ML, Muizelaar JP, Kuta AJ. Documented reversal of global ischemia immediately after removal of an acute subdural hematoma. J Neurosurg. 1994;80:324-327.
13. Yoshino A, Hovda DA, Kawamata T, et al. Dynamic changes in local cerebral glucose utilization following cerebral concussion in rats: evidence of a hyper- and subsequent hypo-metabolic state. Brain Res. 1991; 561:106-119.
14. Katayama Y, Becker DP, Tamura T, et al. Massive increases in extracellular potassium and the indiscriminate release of glutamate following concussive brain injury. J Neurosurg. 1990;73:889-900.
15. Bullock R, Zauner A, Tsuji O, et al. 1995. Patterns of excitatory amino acid release and ionic flux after severe human head trauma, in: Neurochemical monitoring in the intensive care unit. Tsubokawa T., Marmarou A., Robertson C., Teasdale G. (Eds.). Springer-Verlag, Tokyo, pp. 64-77.
16. Unterberg A, Baethmann AJ. The kallikrein-kinin system as mediator in vasogenic brain edema. Part 1: cerebral exposure to bradykinin and plasma. J Neurosurg. 1984;61:87-96.
17. Maier-Hauff K, Baethmann AJ, Lange M, et al. 1984. The kallikrein-kinin system as mediator in vasogenic brain edema. Part 2: Studies on kinin formation in focal and perifocal brain tissue. J Neurosurg. 61:97-106.
18. Unterberg A, Dautermann C, Baethmann A, et al. The kallikrein-kinin system as mediator in vasogenic brain edema. Part 3: Inhibition of the kallikrein-kinin system in traumatic brain swelling. J Neurosurg. 1986; 61:269-276.
19. Wei EP, Ramnarayan RS, Levasseur JE, et al. Effect of local change in O2 saturation of hemoglobin on cerebral vasodilatation from hypoxia and hypotension. Am J Physiol. 1993;265:1439-1443.
20. Di X, Harpold T, Watson JC, et al. Excitotoxic damage in neurotrauma: fact or fiction. Restorative Neurology and Neuroscience. 1996;9:231-241.
21. Tsuchida E, Harms JF, Woodward JJ, et al. A use-dependent sodium channel antagonist, 619C89, in reduction of ischemic brain damage and glutamate release after acute subdural hematoma in the rat. J Neurosurg. 1996;85:104-111.
22. Landolt H, Langemann H, Mendelowitsch A, et al. Neurochemical monitoring and on-line pH measurements using brain microdialysis in patients in intensive care. Acta Neurochir. 1994;60(suppl):475-478.
23. Marion DW, Obrist WD, Carlier PM, et al. The use of moderate therapeutic hypothermia for patients with severe head injuries: a preliminary report. J Neurosurg. 1993;79:354-362.
24. Marion DW, Leonov Y, Ginsberg M, et al. Resuscitative hypothermia. Crit Care Med. 1996;24:S81-S89.
25. Palmer AM, Marion DW, Botscheller ML, et al. Therapeutic hypothermia is cytoprotective without attenuating the traumatic brain injury-induced elevations in interstitial concentrations of aspartate and glutamate. J Neurotrauma. 1993;10:363-372.
26. Broaddus WC, Prabhu SS, Chen ZJ, et al. 1996. High-flow microinfusion of c-myc antisense oligonucleotides prolongs survival in an animal model of imtracranial malignant glioma. CNS, 46th annual meeting, Montreal
27. Stein SC. 1996 In Neurotrauma. Narayan, R.K., Wilberger, J.E., Povlishock, J.T. (Eds.), MccGraw-Hill, New York. 755-765.
28. Clifton GL, Kreutzer JS, Choi SC, et al. Relationship between Glasgow Outcome Scale and neuropsychological measures after brain injury. Neurosurgery. 1993;33:34-39.
29. Marmarou A. Conduct of head injury trials in the United States: The American Brain Injury Consortium (ABIC). Acta Neurochir. 1996;66 (suppl):118-121.
30. Drummond MF, Stoddart GL, Torrance GW. 1987. Methods for the economic evaluation of health care programmes. Oxford Press, Oxford, UK.
31. Choi SC. 1996. Design and analysis of clinical trials of head trauma: endpoints, sample size and early termination. In: Discoveries in head trauma. Savage, L.M. (Ed.), Biomedical Library Series (IBC), Southborough, pp. 67-75.
32. Whitehead J. 1983. The design and analysis of sequential clinical trials. Halsted Press, New York.