Preclinical Evaluation of a Chitosan-Based Field Hemostatic Sponge in Arterial Bleeding Models with and Without...

This study evaluated the hemostatic efficacy of a chitosan-based field hemostatic sponge (FHS), the first hemostatic product of this type manufactured in Vietnam, across bleeding models of varying injury severity under both normal physiological conditions and after aspirin administration.

An in vivo experimental study was conducted using two models: (1) a rabbit ear incision model in New Zealand White rabbits and (2) a femoral artery puncture model in Wistar rats and New Zealand White rabbits. Animals were randomly allocated to six groups: medical gauze (control), FHS, Axiostat^® (reference material), and three corresponding aspirin-treated groups (n = 10 per group for non-aspirin conditions; n = 6 per group for aspirin-treated rabbits; n = 10 per group for aspirin-treated rats). Primary outcomes were time to hemostasis (seconds) and blood loss (mg).

In the rabbit ear incision model, FHS reduced time to hemostasis by 57.6% and blood loss by 69.9% compared with medical gauze (p < 0.001). In the femoral artery puncture model, reductions were 62-65% and 75-76% (p < 0.001). Under aspirin treatment, FHS maintained significant hemostatic advantages over gauze (55-66% reduction in time to hemostasis and 69-76% reduction in blood loss; p < 0.01). No significant difference was observed between FHS and Axiostat^® in any condition (p > 0.05).

FHS demonstrated potent and consistent hemostatic efficacy across multiple injury severities and animal species; the hemostatic efficacy of FHS was maintained after aspirin administration, indicating that the material's efficacy is not entirely dependent on platelet function. These findings support its potential clinical application in hemorrhage control, including in patients with coagulation disorders or receiving antiplatelet therapy.