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

Abstract

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.

Topical haemostatic agents

“…Anticoagulation with aspirin was not found to increase bleeding times in CoStasis ® ‐treated animals7. Heparin anticoagulation, however, did lead to significantly prolonged bleeding, although CoStasis ® remained the fastest acting haemostat and produced the lowest blood loss7, 8.…”

“…Studies in sheep and rabbits suggest that CoStasis ® may be superior to Instat ™ , the fibrin sealant Tisseel ® (Baxter, Deerfield, Illinois, USA), other unbranded investigational fibrin sealants and collagen sponge5, 7, 8. It has also been noted that depletion of platelets or fibrinogen in the autologous plasma used to make up the CoStasis ® solution does not significantly affect times to haemostasis, although depletion of both platelets and fibrinogen may lead to significantly prolonged bleeding times5.…”

“…It has also been noted that depletion of platelets or fibrinogen in the autologous plasma used to make up the CoStasis ® solution does not significantly affect times to haemostasis, although depletion of both platelets and fibrinogen may lead to significantly prolonged bleeding times5. Anticoagulation with aspirin was not found to increase bleeding times in CoStasis ® ‐treated animals7. Heparin anticoagulation, however, did lead to significantly prolonged bleeding, although CoStasis ® remained the fastest acting haemostat and produced the lowest blood loss7, 8.…”

A simple hemostasis model for the quantitative evaluation of hydrogel-based local hemostatic biomaterials on tissue surface

“…The difference between the two P values (0.50 and 0.07) showed how important it is to consider the excess solution for the hemostasis evaluations. It is noteworthy that the subtraction of the excess-solution amount from the total measured bleeding has not been considered in previously reported animal hemostasis models [4,5].…”

“…By means of this method, it was clarified that a hemostatic agent with a sheet-like structure and a hemostatic agent with collagen could stop the bleeding within 3 min, whereas gelatin-sponge or oxidized cellulose materials were less effective. Prior et al proposed a method wherein estimates of total bleeding derived from the weight gained by the preweighted gauze squares or cotton swabs was used to absorb uncoagulated blood from the surgical field of a rabbit kidney [5].…”