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

Abstract

Background Uncontrolled hemorrhage remains the leading cause of preventable death on the battlefield. Hemostatic agents have increased in use and have been shown to improve survival. Combat Gauze (CG) is the most-used hemostatic gauze recommended by the Committee of Tactical Combat Casualty Care. Hemoblast Bellows (HB), a product FDA-approved for intraoperative hemorrhage, contains thrombin which differentiates it from CG and other kaolin-based hemostatic agents and has not been evaluated in the pre-hospital setting. This study aimed to compare HB to CG, in a standard swine arterial hemorrhage model. Methods Dilutional coagulopathy and hypothermia were induced in anesthetized Yorkshire-cross swine. The femoral artery was isolated and a 6 mm femoral arteriotomy was made. After a 30 s free bleed, randomly assigned hemostatic agent(s) from one of the three treatment groups: HB only, CG only, and HB + CG were applied and direct pressure was held for 3 min. At 30 min, the ipsilateral lower extremity was mobilized with a series of hip movements. Primary endpoints included blood loss, rebleeding, thromboelastogram (TEG) values, SPOT GRADE(TM) values, and mean arterial pressure (MAPs), which were monitored during the 150-min observation period. Results There were no significant differences between the treatment groups for blood loss, rebleeding, lactate, TEG values, SPOT GRADE, or MAPs for all time points examined. Conclusions We found no significant differences between the treatment groups for any of the included data points. These results suggest that arterial hemorrhage control with HB alone and HB + CG is not significantly different from hemorrhage control with CG only. These findings should not deter us from a continued investigation of hemostatic agents but should stimulate our search for superior hemorrhage control agents and novel delivery mechanisms. Continued innovation with such products may overcome the product limitations that we observed during testing and may prove to be a more relevant product for the point-of-injury.