HEMOSTATIC EFFICACY OF A FIBRIN SEALANT-BASED TOPICAL AGENT IN A FEMORAL-ARTERY INJURY MODEL - A RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY

Purpose: The efficacy of currently available topical hemostatic agents requires the formation of fibrin generated from circulating blood. Fi brin sealant, which is prepared from high concentrations of thrombin a nd fibrinogen, has been used in liquid form to promote hemostasis duri ng vascular surgery. In a blinded, randomized, placebo-controlled fash ion, we evaluated a dry dressing of purified, viral-inactivated human fibrinogen and human thrombin in a large animal model of arterial inju ry. Methods: Dressings were prepared by application of a layer of lyop hilized human fibrin sealant or immunoglobulin G (IgG, control) to a s ilicone backing material. Six anesthetized female Yorkshire pigs (16 t o 27 kg) received bilateral, 4 mm longitudinal femoral arteriotomies a fter surgical exposure of the arteries. The arteriotomies were not clo sed. In each animal a fibrin sealant dressing was applied to one arter y and a control dressing to the other. Each dressing was secured on th e arteriotomy by a mechanical device, After application of the dressin gs, blood flow was restored to each limb for 1 hour. The compressive d evice was released for 5 seconds at intervals of 15 minutes to assess hemostasis. Blood flow was measured distal to each arteriotomy with a dual-channel flowmeter to adjust equal bilateral compression. Results: Blood loss (mean +/- SEM) was significantly less from the arteriotomy treated with the fibrin-based dressing compared with the control dres sing (4.9 +/- 4.0 mi versus 82.3 +/- 11.1 ml; p = 0.0005). Complete he mostasis was achieved at the first 15-minute interval in five of six a rteriotomies treated with fibrin sealant and in none of the six contro l arteriotomies during 1 hour of assessment (p = 0.03). Blood flow thr ough each femoral artery at baseline was the same in both treatment an d control arteries (fibrin sealant, 114.2 +/- 17.4 ml/min; control, 10 6.7 +/- 16.5 ml/min; p = 0.24) and was not significantly different thr oughout the experiment. Conclusions: Fibrin-based dressings provide ef fective hemostasis in a large animal model of arterial injury. Further development of these dressings will address optimal formulation and c onfiguration for clinical use. Our results suggest that fibrin-based d ressings will be effective in promotion of hemostasis in arterial blee ding, without compromising blood flow.