Evaluation of a novel hemostatic device in an ovine parenchymal organ bleeding model of normal and impaired hemostasis

Abstract

Bleeding is a problem encountered by many surgeons, often complicated by the presence of coagulopathy or anticoagulant. The hemostatic effectiveness of CoStasis Surgical Hemostat (with bovine collagen, bovine thrombin, and autologous plasma) was evaluated and compared to a collagen sponge and to two investigational fibrin-sealant preparations under conditions of normal and impaired coagulation. A liver resection and controlled incisions in spleens and kidneys were made in sheep. Time to complete hemostasis and total blood loss were measured. Tissue response was evaluated at 7, 30, 60, and 75 days. CoStasis-treated sites demonstrated significantly shorter time to hemostasis (all surgical sites combined) compared with fibrin sealant (investigational fibrin sealant 1) (p= .005) or collagen sponge (p=0.013). In anticoagulated animals, CoStasis and fibrin sealant (investigational fibrin sealant 2) had comparable mean times to hemostasis, and CoStasis-treated sites exhibited lowered average blood loss compared to investigational fibrin-sealant-2 treated sites. CoStasis-treated sites demonstrated higher levels of tissue repair (lower inflammation, more extensive tissue repair, and less residual implant) compared to fibrin-sealant- or collagen-sponge-treated sites in Phases I and II. These findings demonstrate that CoStasis is a highly effective hemostatic agent for control of bleeding from parenchymal organs. Furthermore, under conditions of compromised coagulation, treatment with CoStasis demonstrates a reduction in average blood loss when compared to treatment with fibrin sealant.

In vitro capacity of different grades of chitosan derivatives to induce platelet adhesion and aggregation

“…Platelets can adhere to the surfaces of biomaterials. Platelet number counting is an important tool for assessing hemocompatibility as platelet number influences the formation of a hemostatic plug or thrombus [18,19]. Although O-C 53 which is the powdered type of chitosan induced a more rapid reaction among the chitosans studied, O-C 52 in sponge form registered an equivalent result.…”

Acute in-vivo evaluation of bleeding with GelfoamTM plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine

“…The effectiveness of hemostatic agents has been extensively evaluated by bleeding models [8][9][10]. However, these bleeding models have used a dichotomous endpoint to evaluate the attainment of hemostasis (bleeding or no bleeding) rather than a ordinal endpoint over time.…”

A novel synthetic tissue‐adhesive hydrogel using a crosslinkable polymeric micelle

“…In the past few decades, several tissue-adhesive formulations have been developed. These include fibrin glues, 1,2 collagen sheets with fibrin glues, 3 fibrillar collagen, 4 collagen with citric acid derivative, 5 gelatin with resorcin and formalin (GRF glue TM ), 6 albumin with glutaraldehyde, 7 cyanoacrylate, 8 and synthetic polymers. [9][10][11][12] However, these materials have a number of disadvantages and need to be improved for clinical use.…”