Autologous whole blood clot formation with actigraft in patients receiving oral anticoagulant therapy: an ex vivo feasibility study

Abstract

The clotting characteristics of autologous whole blood clots for chronic wound management in patients on anticoagulant therapy are not well defined. An exploratory ex vivo study was performed using the ActiGraft autologous whole blood clot (RedDress Ltd, Haifa, Israel) in patients receiving oral anticoagulant therapy. Twenty-five participants were eligible for inclusion and stratified into three age-matched cohorts: vitamin K antagonist-warfarin (n = 9), factor Xa inhibitor- rivaroxaban (n = 6), and controls not receiving anticoagulation (n = 10). The primary endpoint was clot formation time. Clot formation time was defined as the time point at which no fluid movement was observed. In the study population (median [interquartile range] age 47 [42-52] years), the mean clot formation time was 10.5 ± 2.6 min (reference:8-12 min). Mean clot formation time was significantly different across groups (p < 0.001). Compared with controls (8.4 ± 1.2 min), clot formation time was significantly prolonged in both the warfarin group (11.3 ± 2.3 min; p < 0.002) and the rivaroxaban group (12.7 ± 2.4 min; p < 0.001), with no significant difference between anticoagulant groups (p = 0.297). Nonetheless, complete, stable clots were consistently formed within the expected time frame in all samples across all groups. This illustrates the feasibility of ActiGraft autologous whole blood clot in patients receiving therapeutic anticoagulation. Further studies are indicated in patients with chronic wounds to assess broader safety and efficacy.