Development of a standard swine hemorrhage model for efficacy assessment of topical hemostatic agents.

BACKGROUND The diverse information of efficacy of hemostatic products, obtained from different military laboratories using different models, has made it difficult to ascertain the true benefit of new hemostatic agents in military medicine. The aim of this study was to recommend a standard hemorrhage model for efficacy testing acceptable by most investigators in the field and avoid contradictory and duplicative efforts by different laboratories. METHODS The swine femoral artery injury model (6-mm arteriotomy) with some modifications was tested to standardize the model. The suggested modifications included no splenectomy, one-time treatment, 30 seconds free bleeding, and 5 L limit for fluid resuscitation. The model was tested with all or some of these modifications in four experimental conditions (n = 5-6 pigs per condition) using Combat Gauze (CG) as control agent. RESULTS The primary end points including blood pressure, blood loss, and survival rates were modestly changed in the four conditions. The second experimental condition in which bleeding was treated with a single CG with 3-minute compression produced the most suitable results. The average blood loss was 99 mL/kg, and hemostasis was achieved in one-third of the pigs, which led to matching survival rate. CONCLUSION A rigorous hemorrhage model was developed for future evaluation of new hemostatic agents and comparison with CG, the current standard of care. This model may not be suitable for testing every agent and some modifications may be necessary for specific applications. Furthermore, laboratory studies using this or similar models must be accompanied by operational testing in the field to confirm the efficacy and practical utility of selected agents when used on the battlefield.