A hemostatic hydrogel has high efficacy for the treatment of hemorrhage in a large animal randomized controlled trial.

Abstract

OBJECTIVE: To test the efficacy of a novel hemostatic agent to control high-pressure, high-flow hemorrhage in a large animal model. METHODS: A randomized controlled trial was performed with 18 Holstein calves from January 2023 through January 2024. Following calf randomization, a single carotid arteriotomy incision (3 to 5 mm) was made. In the treatment group, a novel hemostatic hydrogel (TRAUMAGEL) was immediately applied at the site of hemorrhage followed by direct pressure with gauze pads. Calves in the control group received hemorrhage control with direct pressure with gauze pads only. The pads were removed and the arteriotomy site observed at 3, 9, and 19 minutes. Time to hemostasis and severity of any continued hemorrhage were compared. RESULTS: Calves treated with TRAUMAGEL (n = 9) had decreased time to hemostasis and less severe hemorrhage compared with control animals (9; median time to hemostasis, 170 vs 1,134 seconds). CONCLUSIONS: Application of TRAUMAGEL followed by direct pressure decreased time to hemostasis and severity of hemorrhage compared to direct pressure alone. CLINICAL RELEVANCE: TRAUMAGEL may be valuable in large animals for traumatic injury or during surgery for controlling hemorrhage that is accessible to hydrogel application and direct pressure.