Glasgow Outcome Score

The Trial of Org 10172 in Acute Stroke Treatment (TOAST) was a randomized, double-blind, placebo-controlled trial of danaparoid in 1281 patients within 24 hours of onset of acute ischemic stroke. A three-stage dosage regime was used to achieve plasma anti-factor Xa activity of 0.8 unit/mL. Favorable outcome was defined as the combination of a Glasgow Outcome Scale (GOS) score of 1 or 2 and a modified Barthel Index (BI) score of 12 or greater (on a scale of 0-20) at 3 months or 7 days. Very favorable outcome required the combination of a GOS score of 1 and a Barthel Index (BI) score of 19 or 20 at 3 months or 7 days. 

Stroke patients who require mechanical ventilation are not necessarily destined for a poor outcome. In a study by Santoli et al., 58 patients underwent mechanical ventilation and 16 survived. Eleven achieved a Barthel Index (BI) score of 60, indicating a good outcome. Within this study population, those patients with bilaterally absent comeal and pupillary reflexes had uniformly poor outcomes, underscoring the need for careful assessment of brainstem reflexes in intubated stroke patients. Other factors that have been associated with poor outcome in intubated stroke patients are advanced age and lower Glasgow Coma Score (GCS) at the time of intubation, as well as seizures and pulmonary edema. ... 

In clinical studies, posttraumatic hypothermia has also been reported to be beneficial (7,18). Marion et al. (18) demonstrated that posttraumatic hypothermia (32-33°C/24 h) in patients with severe TBI and Glasgow Coma Scores of 5-7 on admission hastened neurologic recovery and may have improved outcome. These clinical findings are impor-... 

For the purpose of the analysis, lactate concentrations were assumed be pseudosteady-state at the beginning of the first DCA dose, so that A i was set to equal the lactate concentration at time 0 multiplied by the estimated A out (A m= A out lactate). A link between the 24 hour post-trauma CSF lactate and 6 month postinjury Glasgow Coma Score (GCS) was also estimated by application of logistic regression to literature data (20). Thus, a PK-exposure-PD-CSF lactate-outcomes model was constructed with the biomarker, CSF lactate, in the center. It must be recognized that this modeling and evaluation of power and efficiency could not be executed without a biomarker. 

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