USage of chitosan for Femoral (USF) haemostasis after percutaneous procedures: a comparative open label study.

Aims: To test the efficacy and safety of a chitosan pad for femoral haemostasis as an adjunct to manual c ompression. Haemostasis of the femoral artery after coronary angiography by manual compression is time consuming and uncomfortable for the patient. Closure devices are costly and do not reduce vascular complication rate. The HemCon ® pad is used by the US army to control traumatic bleeding. It consists of chitosan, a positively charged carbohydrate that attracts the negatively charged blood cells and platelets and promotes clotting. Methods and results: Patients undergoing percutaneous coronary angiography were 1:1 randomised for manual compression with regular or HemCon ® pad. All patients were catheterised with 6 Fr sheath and received 2500 u of heparin. Time to haemostasis, incidence of minor and major bleeding, haematoma size, post-procedural stay at the hospital and level of satisfaction were compared between the two groups. Seventy patients in the HemCon group and 66 patients in the regular pad groups were recruited. Activated clotting time (ACT) before manual compression was similar, 183.9±43.4 and 178.3±34.2 seconds in the HemCon®and regular pad groups respectively. Time to haemostasis was 5.6±2.1 and 8.4±3.5 minutes in the HemCon ® and regular pad groups, respectively (p<0.001). Haematoma developed in 6% and 14.8% of patients in the HemCon®and regular pad group, respectively (p=0.14). Conclusions: The HemCon ® pad significantly decreased time-to-haemostasis compared to the regular pad. The total incidence of haematoma tended to be lower in the HemCon®pad compared to the regular pad group.