Efficacy of a Temporary Hemostatic Device in a Swine Model of Closed, Lethal Liver Injury.

Abstract

Solid abdominal organ hemorrhage remains one of the leading causes of death both on the battlefield of modern warfare and in the civilian setting. A novel, temporary hemostatic device combining CELOX and direct intra-abdominal physical compression was invented to control closed SAOH during transport to a medical treatment facility. A swine model of closed, lethal liver injury was established to determine hemostasis. The animals were randomly divided into group A (extra-abdominal compression), group B (gauze packing), group C (intra-abdominal compression), group D (CELOX coverage), and group E (intra-abdominal compression and CELOX coverage) with six swines per group. Survival time (ST), blood loss (BL), vital signs, pathologic examination, and CT-scan were monitored to further observe the effectiveness of the device. Group E had an average 30-minute extension in ST (74.3±15.4minutes versus 44.0±13.8minutes, p=0.026) with less BL (46.0±13.0 versus 70.8±8.2g/kg, p=0.018), and maintained mean arterial pressure≥70mmHg and cardiac output≥3.5L/minute for a longer time. No significant differences were observed in ST and BL of groups B and E, and there were no marked differences in ST and BL of groups A, C, and D. No CELOX clots were noted in the spleen, pancreas, lungs, heart, kidneys, or the adjacent large vessels in groups D and E. Compared to group A, the CT-scan showed better hepatic hemorrhage control in group E. The device, which combined 20g of CELOX particles and 20 pieces of CELOX (8g) sponge tablets with 50-mmHg intra-abdominal compression for 10minutes, prolonged the ST by an average of 30minutes with less BL. It was not markedly different from the full four quadrants gauze packing of liver in hemostatic effect, with no CELOX clot formation in other organs.