GREENWOOD VILLAGE, Colo., Oct. 1, 2013 /PRNewswire/ -- Luoxis Diagnostics (a subsidiary of Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE), today announced results from a recently completed clinical study of patients with isolated traumatic brain injury (iTBI). This study demonstrated statistically significant correlations between oxidation-reduction potential (ORP) and the severity of injury among iTBI patients. ORP is measured using the company's proprietary RedoxSYS™ diagnostic system, a point-of-care diagnostic system enabling rapid analysis of multiple markers of oxidative stress.
Increases in plasma static oxidation-reduction potential (spot measurement, sORP) levels were consistently shown to closely correlate with increases in iTBI severity as measured by the Abbreviated Injury Score (p=0.02). This prospective observational cohort study of 645 iTBI patients was conducted at two level-one trauma centers in the US over five years, and the analysis was completed in September of 2013.
This is the second clinical study demonstrating the correlation between injury severity in iTBI and oxidation-reduction potential [Rael LT, Bar-Or R, Mains CW, Slone DS, Levy AS, Bar-Or D. Plasma oxidation-reduction potential and protein oxidation in traumatic brain injury. J Neurotrauma 2009;26:1203-1211]. Importantly, this is the first study to show that negative changes in sORP and cORP (a novel measure of patient antioxidant reserves) were associated with poor patient outcomes, including discharge of patients to skilled nursing facilities (SNF) and in-hospital mortality. This study demonstrates the clinical utility of ORP measurements in the overall prognostic assessment of iTBI patients to help predict numerous patient outcomes.Of the 645 patients included in this study, 69% were <65 years old, 61% were males, and median brain Abbreviated Injury Score (AIS) was 3. There were 11 deaths and 56 patients were discharged to a skilled nursing facility. After adjustment in a multivariate logistic regression model, a 20mV increase in the first ORP measurement (obtained within 48 hours of admission) was associated with a 4-fold odds increase of in-hospital mortality (OR: 4.24, 95%CI: 1.2-15.3) and 1.3-fold odds increase of being discharged to a SNF (OR: 1.28, 95%CI: 1.00-1.63). Likewise, decrease in antioxidant reserves, as measured by last inverse Capacity (1/cORP) were associated with significant patients outcomes. For example a 1 unit increase in the last inverse cORP was associated with a 5-fold odds increase in hospital mortality (OR: 5.05, 95%CI 1.2-21.3). Detailed results from this study will be presented at an upcoming scientific meeting.