CytoSorbents Announces Positive REFRESH I Trial Results
MONMOUTH JUNCTION, N.J., May 5, 2017 /PRNewswire/ — Positive results from the REFRESH (REduction in FREe Hemoglobin) I trial were presented on Monday, May 1, 2017 at the American Association for Thoracic Surgery (AATS) Centennial Conference in Boston, MA. REFRESH I was a prospective, randomized, controlled trial in eight major U.S. cardiac surgery centers evaluating the safety and feasibility of CytoSorb®, a blood purification technology designed to treat deadly inflammation in critically-ill and cardiac surgery patients aged 18-80 years of age, where cardiopulmonary bypass (CPB) was expected to exceed 3 hours. Complex cardiac surgery generates high levels of plasma free hemoglobin (pfHb), activated complement, and other inflammatory mediators that can trigger severe post-operative inflammation and complications such as organ dysfunction and organ failure. The CytoSorb® therapy, developed by CytoSorbents Corporation (NASDAQ: CTSO), a leader in critical care immunotherapy, is designed to reduce the risk of these sequelae.
Key findings of the study were:
- Valve replacement surgery (i.e. multiple valve or single valve replacement plus other procedure) was identified as the highest risk procedure for peak pfHb generation (median 123 mg/dL valve replacement vs. 61 mg/dL non-valve replacement controls)
- CytoSorb treatment achieved increasing reductions in peak pfHb levels in this population during surgery compared to control, statistically significant at 3.5h (35 mg/dL; 26% reduction) and 4.0h (61 mg/dL; 38% reduction) of CPB time (p≤0.05)
- Treatment also resulted in statistically significant decreases in activated complement C3a and C5a during surgery
- Achieved the primary safety endpoint of the study with a favorable adjudication of all serious adverse events. There were no significant differences in the rates of adverse events (AEs) or serious adverse events (SAEs) between the two groups, including 30-day mortality, and there were no unanticipated adverse device effects (UADEs) reported.
- CPB led to an expected significant drop in platelets in both groups, with treatment leading to an additional transient and stable decrease in platelets that returned to pre-treatment levels shortly after surgery. Post-operatively, blood coagulation parameters and bleeding complications were not statistically different between the two groups, and an analysis of median transfusion requirements from surgery throughout the ICU stay was not significant (packed red blood cells: 2 vs 2 units control, p=0.15; platelets: 2 vs 1 unit control, p=0.13; plasma: 1 vs 0 units control, p=0.14)
Dr. Joseph B. Zwischenberger, M.D., Chairman and Johnston-Wright Professor of Surgery at University of Kentucky College of Medicine and Principal Investigator of the REFRESH I trial stated, “We are pleased to report on this first multi-center U.S. trial demonstrating the safe and easily implemented use of CytoSorb during high risk complex cardiac surgery. Inflammation and toxic injury from excessive plasma free hemoglobin and activated complement are well-known insults that are associated with organ injury such as acute kidney injury, stroke, lung injury, and other complications. The finding that complex valve replacement procedures generate high levels of pfHb, and that CytoSorb can significantly reduce pfHb and activated complement in this population, represents a potentially important advance in the field. In a future larger study, we plan to correlate the reduction of pfHb and activated complement in this enriched at-risk population with reduced organ dysfunction and injury, while confirming the risk/benefit of the therapy.”
The investigators of the study have submitted a manuscript containing these and additional data for publication. As customary, more data will be made available upon potential future publication.
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