Hemostatic efficacy of two topical adjunctive hemostats in a porcine spleen biopsy punch model of moderate bleeding

Abstract

Topical hemostatic agents have become essential tools to aid in preventing excessive bleeding in surgical or emergency settings and to mitigate the associated risks of serious complications. In the present study, we compared the hemostatic efficacy of SURGIFLO® Hemostatic Matrix Kit with Thrombin (Surgiflo—flowable gelatin matrix plus human thrombin) to HEMOBLAST™ Bellows Hemostatic Agent (Hemoblast—a combination product consisting of collagen, chondroitin sulfate, and human thrombin). Surgiflo and Hemoblast were randomly tested in experimentally induced bleeding lesions on the spleens of four pigs. Primary endpoints included hemostatic efficacy measured by absolute time to hemostasis (TTH) within 5 min. Secondary endpoints included the number of product applications and the percent of product needed from each device to achieve hemostasis. Surgiflo demonstrated significantly higher hemostatic efficacy and lower TTH (p < 0.01) than Hemoblast. Surgiflo-treated lesion sites achieved hemostasis in 77.4% of cases following a single product application vs. 3.3% of Hemoblast-treated sites. On average, Surgiflo-treated sites required 63% less product applications than Hemoblast-treated sites (1.26 ± 0.0.51 vs. 3.37 ± 1.16). Surgiflo provided more effective and faster hemostasis than Hemoblast. Since both products contain thrombin to activate endogenous fibrinogen and accelerate clot formation, the superior hemostatic efficacy of Surgiflo in the porcine spleen punch biopsy model seems to be due to Surgiflo’s property as a malleable barrier able to adjust to defect topography and to provide an environment for platelets to adhere and aggregate. Surgiflo combines a flowable gelatin matrix and a delivery system well-suited for precise application to bleeding sites where other methods of hemostasis may be impractical or ineffective.

Bioactive Hydrogels with Pro‐coagulation Effect for Hemostasis†

“…Many collagen‐ based products, such as Helistat, Avitene, and CoStasis, have been used in preclinical animal bleeding models and clinical applications. [ 80,86‐87 ] Immunogenicity, mechanical properties, and swelling performance are important factors that researchers are concerned about most. To reduce the immunogenicity of collagen, marine collagen [ 88 ] or gelatin, [ 89‐90 ] which is the product of collagen hydrolysis, can be used to achieve hemostasis.…”

“…[ 105‐106 ] Since then, such kind of products were used widely in endoscopic surgery, biopsy perforation, renal resection, urologic injuries, liver surgery, etc . [ 87,89,92,107‐109 ] The catalysis activity maintaining of thrombin is the most important point for design of thrombin immobilized hydrogel.…”

Recent advances in biopolymer-based hemostatic materials

“…Most successful hemostasis depends on patients' clotting capabilities. As a result, the medication efficacy may vary, or hemostatic medications sometimes fail [ 207 ]. While considering the different forms of hemostats or coagulant-loaded hemostats like hydrogel, foams, particles and sheets to stop the bleeding in the injury site [ 116 , 150 , 208 , 209 ].…”

The evaluation of Hemoblast Bellows for arterial hemorrhage control in a swine model of vascular injury

“…It contains the active ingredients of collagen, human thrombin, and chondroitin sulfate. 14 Thrombin converts fibrinogen to fibrin which promotes platelet aggregation. Collagen aids in mechanical hemostasis by creating a controlled swell around the site of injury and works in the coagulation cascade to induce platelet aggregation.…”

“…It also does not require removal from the wound bed as it is naturally resorbed by the body over four weeks. [14][15][16] No previous studies have evaluated the use of HB in either the pre-hospital trauma setting or in severe or extreme hemorrhage. The goal of this study was to determine whether there is a role for the use of HB in TCCC as a stand-alone treatment option or as an adjunct to CG, which is currently the most commonly used hemostatic gauze, using an established swine arterial hemorrhage model.…”