Comparative preclinical evaluation of an investigational topical hemostatic formulation against an active commercial comparator in rat arterial, venous and liver bleeding models under normal and heparinized conditions.

BACKGROUND

An ideal topical hemostatic agent should provide rapid hemostasis, maintain clot stability after manipulation, and preserve a clean operative field. These requirements become particularly relevant under anticoagulated conditions and across different bleeding anatomies.

OBJECTIVE

To evaluate the preclinical performance of a topical hemostatic agent compared with a commercial comparator and saline control in standardized rat arterial, venous, and liver bleeding models under normal and heparinized conditions.

METHODS

A total of 144 adult male Wistar albino rats were allocated to 18 groups (n = 8 per group). Standardized abdominal aortic, vena cava, and liver bleeding models were established under normal and heparinized conditions. Vascular injuries were created with a 21 G needle and liver injury with a standardized 6 mm × 5 mm incision. Treatment was followed by a standardized 3-minute compression protocol. The primary endpoint was time to hemostasis. Liver blood loss was assessed gravimetrically. Rebleeding tendency and operative field quality were evaluated qualitatively.

RESULTS

One-way ANOVA demonstrated overall between-group differences in time to hemostasis in all model-condition combinations (all P < 0.001). Across all anatomical models and coagulation settings, the investigational hemostatic agent consistently showed the shortest mean time to hemostasis, whereas saline-treated controls showed the longest times. Pairwise post hoc comparisons showed significantly shorter time-to-hemostasis values for the investigational agent than for the commercial comparator in four of the six model-condition comparisons; in the remaining two comparisons, the mean time-to-hemostasis values were numerically lower but not statistically significant. In the liver model, mean blood loss was numerically lowest in the investigational groups under both normal and heparinized conditions, although between-group differences were not statistically significant. Descriptive qualitative observations suggested cleaner operative fields and less post-manipulation rebleeding in the investigational groups.

CONCLUSION

In this standardized multi-model rat study, the investigational topical hemostatic agent showed consistently shorter mean time-to-hemostasis values across arterial, venous, and liver bleeding models under both normal and heparinized conditions. Liver blood loss was numerically lower in the investigational groups, but the between-group differences were not statistically significant. These findings support further confirmatory preclinical evaluation.