1. Clinical Implications of D-Stat ® Dry in the Trauma Setting Gundu H. R. Rao*, Debra Cocking Johnson*, Steve Penegor**, Daniella Jentzsch** *Blood Biocompatibility Laboratory, University of Minnesota, Minneapolis, MN **Vascular Solutions, Inc., Minneapolis, MN Background Of the over 110 million Emergency Department visits each year, an estimated 35% are injury related, with open wounds being the most frequently reported diagnosis. Over the past several years, a number of topical hemostasis devices have been developed to control surface bleeding. Only one, D-Stat Dry (Vascular Solutions, Minneapolis MN), contains the active clotting agent thrombin which accelerates hemostasis through the cleavage of endogenous fibrinogen to fibrin, activates the coagulation cascade, and stimulates platelet aggregation. Figure #1 Time for citrated blood to clot following device exposure. Clinical Case #1 An obese diabetic male presented with a deep flank ulceration with severe arterial hemorrhaging. Methods to secure hemostasis included: approximately 1.5 hours of manual compression, manual compression with GelFoam within the wound, and cauterization. A D-Stat Dry 3x3 hemostatic pad was used while a bariatric surgical team was being assembled. The pad was applied with adjunctive manual compression. Within 5 minutes of application, the bleeding was arrested. The bariatric surgeon evaluated the wound and determined that successful hemostasis was obtained. The pending surgical intervention was cancelled. Clinical Case # 2 A dialysis patient presented post- hemodialysis treatment. A standard pressure clamp was in place over an indwelling AV shunt. Removal of the compression device revealed a vigorous arterial bleed. A D-Stat Dry 3x3 hemostatic pad was sectioned into a 2 inch by 2 inch pad and applied directly over the puncture site and the compression clamp was reapplied. A hemostasis check performed at 10 minutes post-application confirmed complete cessation of bleeding. The patient was observed for one hour without incident and discharged. The Power of Thrombin In order to demonstrate the clinical implications of D-Stat Dry in the Emergency Department (ED), the hemostatic abilities of D-Stat Dry were compared in-vitro to Clo-Sur P.A.D.™ (Scion Cardiovascular, Miami FL), Hemaderm™ (Medafor, Minneapolis MN), Chito-Seal™ (Abbott Cardiovascular, Redmond City CA), Neptune Pad (TZ Medical, Portland OR), Syvek® (Marine Polymer Technologies, Danvers MA), and a non-woven gauze pad. The evaluation consisted of standardized coagulation and hematology assays, including Whole Blood Clot Test (aka Modified Lee-White Coagulation Assay), Platelet Aggregation, and Platelet-Red Blood Cell Adhesion/Agglutination. As depicted in Figure 1, which summarizes the time in minutes it took for citrated blood to clot following recalcification and device exposure, the D- Stat Dry device was found to be superior in the areas of citrated blood clotting time and platelet aggregation. The D-Stat Dry was more than 12 times faster than the next closest device in clotting citrated blood, and brought on platelet aggregation almost 10 times faster than any other device. Indications for Use D-Stat Dry is: - Applied topically - Indicated as an adjunct for the control of surface bleeding the control of surface bleeding from vascular access sites and from vascular access sites and percutaneous catheters or percutaneous catheters or tubes tubes D-Stat Dry 3x3 hemostatic pad (Thrombix®) is: - Applied topically - Indicated as a trauma dressing for temporary control of for temporary control of moderate to severely bleeding moderate to severely bleeding wounds and for the control of wounds and for the control of surface bleeding from vascular surface bleeding from vascular access sites and percutaneous access sites and percutaneous catheters or tubes catheters or tubes Conclusions As observed in the clinical case studies, D-Stat Dry, which utilizes the power of thrombin, is effective in treating a range of moderate to severely bleeding wounds. The timely treatment of patients presenting with open wounds (such as lacerations, punctures, or abrasions) may reduce the time to discharge, and in turn help decrease the overcrowding of hospital emergency departments. Figure #2: D-Stat Dry Indications for Use