Browsing by Author "Tator, Charles"
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Item Open Access A prospective, multicenter, phase I matched-comparison group trial of safety, pharmacokinetics, and preliminary efficacy of riluzole in patients with traumatic spinal cord injury.(Journal of neurotrauma, 2014-02) Grossman, Robert G; Fehlings, Michael G; Frankowski, Ralph F; Burau, Keith D; Chow, Diana SL; Tator, Charles; Teng, Angela; Toups, Elizabeth G; Harrop, James S; Aarabi, Bizhan; Shaffrey, Christopher I; Johnson, Michele M; Harkema, Susan J; Boakye, Maxwell; Guest, James D; Wilson, Jefferson RA prospective, multicenter phase I trial was undertaken by the North American Clinical Trials Network (NACTN) to investigate the pharmacokinetics and safety of, as well as obtain pilot data on, the effects of riluzole on neurological outcome in acute spinal cord injury (SCI). Thirty-six patients, with ASIA impairment grades A-C (28 cervical and 8 thoracic) were enrolled at 6 NACTN sites between April 2010 and June 2011. Patients received 50 mg of riluzole PO/NG twice-daily, within 12 h of SCI, for 14 days. Peak and trough plasma concentrations were quantified on days 3 and 14. Peak plasma concentration (Cmax) and systemic exposure to riluzole varied significantly between patients. On the same dose basis, Cmax did not reach levels comparable to those in patients with amyotrophic lateral sclerosis. Riluzole plasma levels were significantly higher on day 3 than on day 14, resulting from a lower clearance and a smaller volume of distribution on day 3. Rates of medical complications, adverse events, and progression of neurological status were evaluated by comparison with matched patients in the NACTN SCI Registry. Medical complications in riluzole-treated patients occurred with incidences similar to those in patients in the comparison group. Mild-to-moderate increase in liver enzyme and bilirubin levels were found in 14-70% of patients for different enzymes. Three patients had borderline severe elevations of enzymes. No patient had elevated bilirubin on day 14 of administration of riluzole. There were no serious adverse events related to riluzole and no deaths. The mean motor score of 24 cervical injury riluzole-treated patients gained 31.2 points from admission to 90 days, compared to 15.7 points for 26 registry patients, a 15.5-point difference (p=0.021). Patients with cervical injuries treated with riluzole had more-robust conversions of impairment grades to higher grades than the comparison group.Item Open Access Demographics, Mechanism of Injury and Outcomes for Acute Upper and Lower Cervical Spinal Cord Injuries - An Analysis of 470 Patients in the Prospective, Multicenter North American Clinical Trials Network (NACTN) Registry.(Journal of neurotrauma, 2023-02) Futch, Brittany Grace; Kouam, Romaric Waguia; Ugiliweneza, Beatrice; Harrop, James; Kurpad, Shekar; Foster, Norah; Than, Khoi; Crutcher, Clifford; Goodwin, C Rory; Tator, Charles; Shaffrey, Christopher I; Aarabi, Bizhan; Fehlings, Michael; Neal, Chris J; Guest, James; Abd-El-Barr, Muhammad MThere is a paucity of data comparing the demographics, mechanism of injury, and outcomes of upper versus lower cervical spinal cord injuries (cSCI). The study objective was to define different clinical manifestations of cSCI. Data were collected prospectively through centers of the North American Clinical Trials Network (NACTN). Data was collected on 470 patients (21% women, mean age 50 years). Cervical vertebral level was analyzed as an ordinal variable to determine a natural demarcation to classify upper versus lower cSCI. For continuous variable analysis, falls were associated with C3 more than C4 vertebral level injuries (60% vs. 42%) (p=0.0126), while motor vehicle accidents (MVA) were associated with C4 more than C3 (40% vs. 29%) (p=0.0962). Motor ISNSCI scores also demonstrated a natural demarcation between C3 and C4, with C3 having higher median ASIA motor scores (40 [4 - 73] vs. 11 [3 - 59], p= 0.0227). There were no differences when comparing C2 to C3 nor C4 to C5. Given the significant differences seen between C3 and C4, but not C2 and C3 nor C4 and C5, upper cSCI was designated as C1-C3, and lower cSCI was designated as C4-C7. Compared to a lower cSCI, patients with an upper cSCI were more likely to have a fall as their mechanism of injury (54% vs. 36%, p= 0.0072). Patients with an ASIA C cSCI were likely to have an upper cervical injury: 23% vs. 11% (p= 0.0226). Additionally, patients with an upper cSCI were more likely to have diabetes prior to injury, 37% vs. 22% respectively (p= 0.0084). Lower cSCI were more likely injured through sports (19% vs. 8%, p= 0.0171) and present with ASIA A (42% vs. 25%, p= 0.0186) neurological grade. Patients with lower cSCI were also significantly more likely to have complications such as shock, pulmonary embolism, and pleural effusion. In conclusion, there appears to be a natural demarcation of injury type between C3 and C4. Upper cSCI (C1-C3) was more associated with falls and diabetes, whereas lower cSCI (C4-C7) was more associated with sports, worse ASIA scores, and more complications. Further research will be needed to understand the mechanistic and biological differences between these two groups and whether different treatments may be appropriate for each of these groups.Item Open Access Variability in Early Surgery for Acute Cervical Spinal Cord Injury Patients: An Opportunity for Enhanced Care Delivery.(Journal of neurotrauma, 2023-04) Neal, Chris J; Ugiliweneza, Beatrice; Toups, Elizabeth G; Abd-El-Barr, Muhammad; Jimsheleishvili, George; Kurpad, Shekar N; Aarabi, Bizhan; Harrop, James Shields; Shaffrey, Christopher; Fehlings, Michael G; Tator, Charles; Grossman, Robert; Guest, JamesData supporting the benefits of early surgical intervention in acute spinal cord injury (SCI) is growing. For early surgery to be accomplished, understanding the causes of variabilities that effect the timing of surgery is needed to achieve this goal. The purpose of this analysis is to determine factors that affect the timing of surgery for acute cervical SCI within the North American Clinical Trials Network (NACTN) for SCI registry. Patients in the NACTN SCI registry from 2005 to 2019 with a cervical SCI, excluding Acute Traumatic Central Cord Syndrome, were analyzed for time elapsed from injury to arrival to the hospital, and time to surgery. Two categories were defined: 1) Early Arrival with Early Surgery commenced within 24 hours of injury (EAES) and 2) Early Arrival but Delayed Surgery (EADS) with surgery occurring between 24 to 72 hours post-injury. Patients' demographic features, initial clinical evaluation, medical comorbidities, neurological status, surgical intervention, complications, and outcome data were correlated with respect to the two arrival groups. Of the 222 acute cervical SCI patients undergoing surgery, 163 (73.4%) were EAES, and 59 (26.6%) were EADS. There was no statistical difference in arrival time between the EAES and EADS groups. There was a statistical difference in the median arrival time to surgery between the EAES group (9 hours) compared to the EADS group (31 hours) (p<0.05). There was no statistical difference in race, sex, age, mechanism of injury, APACHE II scores, or medical comorbidities between the two groups but the EAES group did present with a significantly lower systolic blood pressure (p<0.05). EADS patients were more likely to present as an AIS D than EAES (p<0.05). Early surgery was statistically more likely to occur if the injury occurred over the weekend (p<0.05). There were variations in the rates of early surgery between the 8 NACTN sites within the study, ranging from 57% to 100%. Of the 114 patients with 6-month outcome data, there was no significant change between the two groups regarding AIS grade change and motor/pin prick/light touch score recovery. A trend towards improved motor scores with early surgery was not statistically significant (p=0.21). Although there is data that surgery within 24 hours of injury improves outcomes and can be performed safely, there remain variations in care outside of clinical trials. In the present study of cervical SCI, NACTN achieved its goal of early surgery in 73.4% of patients from 2005-2019 who arrived within 24 hours of their injury. Variability in achieving this goal was related to severity of neurological injury, the day of the week, and the treating NACTN center. Evaluating variations within our network improves understanding of potential systemic limitations and our decision-making process to accomplish the goal of early surgery.