High-pressure fibrin sealant foam: an effective hemostatic agent for treating severe parenchymal hemorrhage.
ABSTRACT The majority of early trauma deaths are related to uncontrolled, noncompressible, parenchymal hemorrhage from truncal injuries. The purpose of this study was to formulate a fibrin sealant foam (FSF) able to control severe parenchymal bleeding without compression or vascular control.
FSF with high fibrinogen concentration (20 mg/mL) and low thrombin activity (5 U/mL) was prepared and pressurized by addition of liquid gas propellant. The efficacy of this foam was tested against a severe parenchymal hemorrhage, created by partial resection of liver lobes in anticoagulated rabbits (n = 7) and compared to untreated injury (n = 8) and placebo treatment (n = 7). The hemostatic efficacy of pressurized FSF (n = 8) was also compared to a commercially available liquid fibrin sealant (n = 8) and a developing dry powdered fibrin sealant product (n = 8) in the same model.
The liver injury resulted in 122 +/- 11.5 mL blood loss and death of 75% of untreated rabbits (3.2-3.4 kg) within 1 h. Treatment with placebo foam had no effect on blood loss or mortality rate. Pressurized FSF significantly reduced bleeding, resulting in 56% (P < 0.05) and 66% (P < 0.01) reduction in blood loss as compared to untreated or placebo-treated animals, respectively, and 100% survival (P = 0.008). When pressurized FSF was compared with liquid and powdered forms of fibrin sealant, only foam significantly reduced blood loss (49%, P < 0.05) and mortality rate (54%, P < 0.05) of rabbits as compared to untreated control animals (n = 9).
Biological nature, rapid preparation, coverage of large wound areas, and effective hemostatic properties make pressurized FSF an ideal candidate for treating nonoperable parenchymal injuries in damage control procedures.
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ABSTRACT: The use of mineral (clay) or biologic (chitosan) materials has improved the efficacy of dressings used in the bleeding control of noncompressible areas. A series of novel manufactured products already evaluated in a vascular transection model was further compared in a severe vascular puncture injury model. Ten hemostatic dressings were tested in anesthetized Yorkshire swine hemorrhaged for 45 seconds in a femoral arterial puncture model. Application of these dressings was followed by 5 minutes of compression (about 175 mm Hg), and at 15 minutes, 500 mL resuscitation fluid (Hextand) was infused during a 30-minute period. The animals were monitored for a 3-hour experimental observation period. Primary outcomes were incidence of bleeding after dressing application and animal survival. Blood loss was 18.8% +/- 5.2% estimated blood volume (EBV) after 45 seconds of free bleeding. Relative performance of dressings is characterized as groups of dressings that performed similarly. Recurrence of bleeding after application was observed with most dressings and was lower with Woundstat, Celox, X-Sponge, and ACS+ (35% +/- 49%) compared with FP-21, Hemcon, Chitoflex, and Bloodstop (79% +/- 43%; P < .01). Blood loss after treatment was 25.3% +/- 18.4% EBV for the top four dressings and 53.0% +/- 18.4% EBV for the bottom four (P < .05). Survival was higher for top four vs bottom four dressings (78% +/- 12% vs 25% +/- 0%, respectively; P < .01). Overall performance of these dressings according to survival, incidence of bleeding, and post-treatment blood loss, yielded similar ranking as with a previously tested transection injury model. The findings indicated that the efficacy of Woundstat, Celox, X-Sponge, and ACS+ were similar and superior in improving survival, hemostasis, and maintenance of mean arterial pressure in an actively bleeding wound caused in this severe vascular injury model.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 09/2009; 50(3):632-9, 639.e1. · 3.52 Impact Factor