USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous

USF Hemostasis USage of HemCon for Femoral Hemostasis after Percutaneous Procedures A Comparative Open Label Study Introduction After completion of angiography performed via the femoral artery, hemostasis is achieved by applying local pressure either manually or by mechanical devices for 10-20 minutes. This is time consuming for the physician, uncomfortable for the patient and occasionally complicated with vascular events that increase morbidity and hospital duration and reduce patient satisfaction. Closure devices have been developed to shorten pressure time but they are costly.

The HemCon pad is composed of a bandage containing a carbohydrate called chitosan, found in the shells of shrimp, lobster and beetles. Its molecules are positively charged and attract the negatively charged blood cells and platelets, and thus promote clotting. Chitosan hemorrhage control dressings have been shown to be effective in animal models of severe hemorrhage (1-4). Bandage. U.S. military personnel in the Iraquean and Afghanistan conflicts have used the HemCon Bandage to successfully stop arterial hemorrhage not controlled by conventional bandages in more then 64 patients without adverse effects (3,5). The HemCon bandage is also an FDA-cleared hemostatic dressing suitable for use in hemodialysis access puncture (2).

The purpose of this trial is to test HemCon pad after diagnostic percutaneous coronary angiography as an adjunct to manual compression to better control vascular access site bleeding and reduce time-to-hemostasis.

We hypothesize that the use of HemCon bandage will shorten the time needed to achieve hemostasis, time to patient's ambulation, and patient's satisfaction without increasing vascular complications.

Endpoints Primary endpoint