ClotFoam is a novel crosslinked polymer designed to stop hemorrhage without compression in severe wounds outside the operating room. ClotFoams ability to promote hemostasis in cases severe bleeding is based on the physical and coagulation properties of a fibrin sealant embedded in a gelatin support and enhanced by procoagulants, ions and molecules that increase the affinity to collagen. It is presented in 2 solutions that when mixed form a strong coating over lacerated tissue. CloFoam is delivered through a Veress needle, and distributed throughout the cavity in the form of a foam produced by a non-toxic foam inducer. Studies in rats and rabbits have shown that ClotFoam adheres to the abdominal cavity, even under profuse bleeding, initiating a rapid clot formation. Phase I proposed studies will provide the proof of concept for the use ClotFoam in cases of non-compressible hemorrhage by establishing its ability to adhere to lacerated tissue in a pool of blood using a rat aortic model. Phase II studies will establish the efficacy and safety in military relevant models (pigs) with induced intraperitoneal non-compressible hemorrhage secondary to grade IV/V traumatic liver damage. The study will evaluate restoration of vital functions and survival and achievement of hemostasis,
Keywords: Hemostatic Agents, Non-Compresible Hemorrhage, Wound Sealants, Fibrin Clot, Tissue Regeneration, Gelatin.
