Efficacy of a novel hemostatic agent in animal models of impaired hemostasis

This study evaluated the efficacy of a novel sprayable hemostat under both normal conditions and those of compromised coagulation. CoStasistrade mark Surgical Hemostat ("CoStasis"), containing collagen, thrombin, and autologous plasma, was compared to Instattrade mark collagen sponge, an investigational fibrin sealant, and a no treatment control, for the ability to control bleeding in a rabbit kidney model. Hemostatic performance was determined by time to hemostasis and blood loss in a nonsurvival, randomized, in vivo bleeding rabbit kidney model. Under conditions of normal coagulation, as well as aspirin and heparin treatment, hemostasis was achieved faster with CoStasistrade mark than with Instattrade mark and fibrin sealant. With the exception of the time to hemostasis using Instattrade mark sponge in heparinized rabbits, all differences were statistically significant (p < 0.03, Wilcoxon). Blood loss, where measured, was lower with CoStasistrade mark than with the other hemostats under the three coagulation conditions. Statistical significance, (p < 0.03, Wilcoxon), was achieved with all comparisons except with fibrin sealant in aspirin treated animals. The combination of collagen, thrombin, and autologous plasma used in CoStasis, can achieve significantly faster hemostasis than the conventional atraumatic hemostats, collagen sponge, and fibrin sealant under normal conditions and conditions of impaired hemostasis.