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Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data

Results of the second National Acute Spinal Cord Injury Study

Michael B. Bracken, Mary Jo Shepard, William F. Collins Jr., Theodore R. Holford, David S. Baskin, Howard M. Eisenberg, Eugene Flamm, Linda Leo-Summers, Joseph C. Maroon, Lawrence F. Marshall, Phanor L. Perot Jr., Joseph Piepmeier, Volker K. H. Sonntag, Franklin C. Wagner Jr., James L. Wilberger, H. Richard Winn and Wise Young

A randomized double-blind clinical trial of the efficacy of very high doses of methylprednisolone or naloxone, compared with placebo, in the early treatment of acute spinal cord injury was conducted. In a previous report, 8 we have shown that neurological function is significantly improved 6 weeks and 6 months after injury among patients starting methylprednisolone treatment within 8 hours of injury. In this paper, we report the 1-year follow-up results of this trial: the second National Acute Spinal Cord Injury Study (NASCIS). We provide further details

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Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up

Results of the third National Acute Spinal Cord Injury Randomized Controlled Trial

Michael B. Bracken, Mary Jo Shepard, Theodore R. Holford, Linda Leo-Summers, E. Francois Aldrich, Mahmood Fazl, Michael G. Fehlings, Daniel L. Herr, Patrick W. Hitchon, Lawrence F. Marshall, Russ P. Nockels, Valentine Pascale, Phanor L. Perot Jr., Joseph Piepmeier, Volker K. H. Sonntag, Franklin Wagner, Jack E. Wilberger, H. Richard Winn and Wise Young

P harmacological approaches for clinical improvement of neurological function in the treatment of acute spinal cord injury have been studied since 1977, primarily in three Phase III double-blind randomized clinical trials. In the first National Acute Spinal Cord Injury Study (NASCIS I), a 100-mg/24-hour regimen of methylprednisolone (MP) was compared with a 1000-mg/24-hour regimen, both administered over a 10-day period beginning within 48 hours after admittance to a spinal cord injury center in patients who had experienced traumatic spinal cord injury. 5, 9

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Jason S. Cheng, R. Mark Richardson, Alisa D. Gean and Shirley I. Stiver

axial image showing signal change in the medulla, predominantly on the right side (arrow) . C: Axial T2-weighted image demonstrating areas of signal hyperintensity in the spinal cord at the C-2 level with more extensive involvement on the left than the right side. Discussion In this case, bullet migration from the posterior fossa to the cervical spinal cord caused an acute spinal cord injury with quadriparesis, sensory deficit, and sphincter dysfunction. Migration of bullets in the cranial vault occurs in an estimated 4% of gunshot injuries to the head. 26

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Charles H. Tator, Michael Fehlings, Kevin Thorpe and Wayne Taylor

T he Surgical Treatment for Acute Spinal Cord Injury Study (STASCIS) group was formed in 1992 by the Spinal Cord Injury Committee of the Joint Section on Neurotrauma and Critical Care of The American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS), the two largest neurosurgical specialty organizations in North America. In 1996, STASCIS was joined by the Joint Section on Spinal Disorders and Peripheral Nerves of The AANS and CNS. The principal aim of the STASCIS group was to conduct a randomized prospective controlled

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Diana S. L. Chow, Yang Teng, Elizabeth G. Toups, Bizhan Aarabi, James S. Harrop, Christopher I. Shaffrey, Michele M. Johnson, Maxwell Boakye, Ralph F. Frankowski, Michael G. Fehlings and Robert G. Grossman

improve functional outcome after SCI in humans. Clinical trials with methylprednisolone (NASCIS [National Acute Spinal Cord Injury Study] II and III), 8 , 9 GM-1 ganglioside, 17 fampridine (4-aminopyridine), 22 , 23 , 38 and lithium carbonate 58 , 59 have provided suggestive but equivocal evidence of benefit. In light of the overwhelming impact of SCI on the individual, new therapeutic interventions are urgently needed. Compelling evidence exists that riluzole, a sodium-channel blocking agent with antiglutamatergic activity, offers promise for improving the

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Charles H. Tator and Michael G. Fehlings

In this paper the authors review the clinical trials of neuroprotection that have been performed for the treatment of acute spinal cord injury (SCI). The biological rationale for the selection of each treatment modality is discussed with reference to current knowledge of the principles in the management of acute SCI as well as the primary and secondary injury mechanisms identified by experimental and clinical studies of the pathophysiology of acute SCI. The trials are evaluated with regard to the availability and use of accurate clinical outcome measures, and the methodologies of the trials are critically evaluated with an emphasis on prospective randomized controlled studies. A detailed description and critical analysis are provided of the results of the 10 clinical trials conducted to date in which a randomized prospective controlled design has been used. The issue of the therapeutic time window in acute SCI is discussed. To date, methylprednisolone is the only effective neuroprotective agent that has been established for use in human SCI, and the only therapeutic time window established in human SCI is a maximum trauma-to-treatment time of 8 hours.

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Mitsuhiro Yanase, Takashi Sakou and Takeo Fukuda

O f the numerous experimental studies that have been conducted to examine pathophysiological changes after acute spinal cord injury, most are consistent with a two-step damage mechanism of the spinal cord, in which the primary or mechanical injury is caused by an external force and secondary or progressive autodestructive injury of the cord follows. 1–3, 12, 13, 20 Factors believed to play a significant role in the progressive posttraumatic autodestruction include changes in spinal microcirculation, 22, 28 norepinephrine release, 18, 30 cell membrane damage

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Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up

Results of the third National Acute Spinal Cord Injury randomized controlled trial

Michael B. Bracken, Mary Jo Shepard, Theodore R. Holford, Linda Leo-Summers, E. Francois Aldrich, Mahmood Fazl, Michael G. Fehlings, Daniel L. Herr, Patrick W. Hitchon, Lawrence F. Marshall, Russ P. Nockels, Valentine Pascale, Phanor L. Perot Jr., Joseph Piepmeier, Volker K. H. Sonntag, Franklin Wagner, Jack E. Wilberger, H. Richard Winn and Wise Young

Object

A randomized double-blind clinical trial was conducted to compare neurological and functional recovery and morbidity and mortality rates 1 year after acute spinal cord injury in patients who had received a standard 24-hour methylprednisolone regimen (24MP) with those in whom an identical MP regimen had been delivered for 48 hours (48MP) or those who had received a 48-hour tirilazad mesylate (48TM) regimen.

Methods

Patients for whom treatment was initiated within 3 hours of injury showed equal neurological and functional recovery in all three treatment groups. Patients for whom treatment was delayed more than 3 hours experienced diminished motor function recovery in the 24MP group, but those in the 48MP group showed greater 1-year motor recovery (recovery scores of 13.7 and 19, respectively, p = 0.053).A greater percentage of patients improving three or more neurological grades was also observed in the 48MP group (p = 0.073). In general, patients treated with 48TM recovered equally when compared with those who received 24MP treatments. A corresponding recovery in self care and sphincter control was seen but was not statistically significant. Mortality and morbidity rates at 1 year were similar in all groups.

Conclusions

For patients in whom MP therapy is initiated within 3 hours of injury, 24-hour maintenance is appropriate. Patients starting therapy 3 to 8 hours after injury should be maintained on the regimen for 48 hours unless there are complicating medical factors.

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Michael B. Bracken and Theodore R. Holford

DJ : Comparison of functional and medical assessment in the classification of persons with spinal cord injury. J Rehab Res Devel 30 : 405 – 411 , 1993 Bednarczyk JH, Sanderson DJ: Comparison of functional and medical assessment in the classification of persons with spinal cord injury. J Rehab Res Devel 30: 405–411, 1993 3. Bracken MB : Pharmacologic interventions for acute spinal cord injury (Cochrane Review) , in: The Cochrane Library Issue 3 , 2001 . Oxford : Update Software Bracken MB: Pharmacologic

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Sanjay S. Dhall, Shekar N. Kurpad, R. John Hurlbert and Praveen V. Mummaneni

Hurlbert RJ , Hadley MN , Walters BC , Aarabi B , Dhall SS , Gelb DE , : Pharmacological therapy for acute spinal cord injury . Neurosurgery 76 ( Suppl 1 ): S71 – S83 , 2015 3 Levi AD , Anderson KD , Okonkwo DO , Park P , Bryce TN , Kurpad SN , : Clinical outcomes from a multi-center study of human neural stem cell transplantation in chronic cervical spinal cord injury . J Neurotrauma [epub ahead of print], 2018 30180779 4 Walters BC , Hadley MN , Hurlbert RJ , Aarabi B , Dhall SS , Gelb DE , : Guidelines