Novel silica-based polymer hemostatic matrix improves vessel patency rates in a coagulopathic porcine model with penetrating arterial injury

BACKGROUND Traumatic hemorrhage is the leading cause of preventable battlefield death and hemostatic agents can improve survival. We compared a novel, amorphous, silica dioxide-based fiber (SBF) hemostatic matrix to the criterion standard QuikClot Combat Gauze (QCCG) in treating a junctional arterial injury in hypocoagulable swine. METHODS Vascular access was obtained in 16 anesthetized swine, and hemodilution was achieved with 50% blood exchange with saline. A 5-mm arteriotomy was made in the common femoral artery. After 30 seconds of free bleeding, SBF or QCCG was applied, and pressure was held for 5 minutes. After 1 hour of monitoring, an angiogram and movement test were performed. Samples were drawn for blood count, chemistry, blood gas and rotational thromboelastography at various time points. The artery and hindlimb were collected for histology. RESULTS All animals (n = 8/group) survived. Hemodilution induced significant differences in hematocrit, platelets, clot formation time, and maximum clot firmness (p < 0.0001). There was no difference in blood counts or chemistries (p = 0.81-0.99) between groups at euthanasia. SBF required an average of 1.25 applications compared with 1.13 for QCCG (p > 0.99). SBF had significantly less blood loss (106.2 ± 66.6 mL) versus QCCG (189.6 ± 78.9 mL, p = 0.038). Angiography revealed patency with distal perfusion in all (8/8) SBF-treated animals. Alternatively, all QCCG-treated arteries were occluded without distal perfusion, which was statistically significant (p < 0.01). All animals remained hemostatic after the movement test. Blinded histopathological analysis revealed only two of eight cases of tunica intimal thickening and neutrophils in the QCCG group, which was not statistically different. CONCLUSION SBF and QCCG had comparable hemostatic efficacy and no difference in the number of applications, despite SBF packaging containing less material. There was no evidence of significant laboratory abnormalities at the study conclusion. Taken together, SBF may be an appropriate hemostatic agent for hemorrhagic injury and is able to maintain hemostasis following stressed movement. Its improved vessel patency suggests SBF may decrease tissue ischemia and improve limb salvage in vascular injuries.