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Isotonic saline solution (0.9% sodium chloride) is utilized as the placebo control arm in a Phase 2 clinical trial (NCT04531579) sponsored by Westat. This study evaluates the efficacy of valproic acid (VPA) in mitigating ischemia/reperfusion (I/R) injury and preventing acute kidney injury (AKI) in trauma patients suffering from moderate-to-severe hemorrhage. In the trial, the control group receives a 300 ml intravenous infusion of the saline solution, which serves as a volume-matched comparator to the VPA treatment arm. While isotonic saline is a standard crystalloid used for fluid resuscitation and volume expansion, in this specific regulatory context, it functions as the inactive comparator to assess the neuroprotective and organ-protective effects of VPA following hemorrhagic shock.
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