Reduction of femoral arterial bleeding post catheterization using percutaneous application of fibrin sealant

Abstract

The number of cardiac catheterizations performed yearly is growing with correspondingly increasing amounts of morbidity, complications, and hospital costs. This study suggests that fibrin sealant instillation via an arterial sheath at the completion of femoral catheterization may improve hemostasis. Results using fibrin sealant in 12 unheparinized dogs documented significant reductions (McNemar's exact test) versus control for groin ecchymoses (1 versus 8, P = .008) and radiolabeled hematoma formation (0 versus 7, P = .016). Also swelling was less in the fibrin sealant treated groins when compared to control groins (1 versus 6, P = .125), but failed to reach statistical significance. Results in eight heparinized dogs (activated clotting time 374 +/- 22, mean +/- SEM) revealed a statistically significant reduction in signs of gross bleeding in the fibrin sealant-treated groins (1 versus 8, P = .016). This method may contribute to reduced morbidity, complications, and length of hospitalization. It may also allow for earlier patient mobilization after cardiac catheterization.

Reduction of femoral artery bleeding post catheterization using a collagen enhanced fibrin sealant

“…This study documents a similar efficacy as compared to a previous study which employed an identical model to administer a fibrin sealant without collagen [43]. The animals used in this study were heparinized to a larger but similar extent as the animals in the earlier study (activated clotting time of 396 6 107 compared to 374 6 22).…”

“…This study did not demonstrate a clear advantage for collagen enhanced fibrin sealant over standard forms of fibrin sealant [43] either because the sample size was limited, because smaller volumes of sealant were used, or because no significant difference exists. The animals were observed for a period of only five minutes following completion of compression.…”

“…The animals used in this study were heparinized to a larger but similar extent as the animals in the earlier study (activated clotting time of 396 6 107 compared to 374 6 22). Moreover, a smaller volume of collagen enhanced fibrin sealant was administered in this study, a mixture of 3 ml collagen enhanced fibrinogen and 3 ml thrombin, as compared to the 4 ml fibrinogen combined with 4 ml thrombin [43]. Despite the smaller amount of adhesive in this study and the small difference in heparinization of the animals, the investigational product was effective at controlling hemorrhage, as illustrated in Figure 1.…”

“…An identical catheter system was employed as was described in detail and used in a previous study [43] in order to avoid injecting the sealant into the artery. An arterial sheath was linked to the adhesive administration assembly via an introducer, which was positioned with its tip entirely within the body of the sheath.…”

“…Fibrin sealant shares with collagen its extensive clinical use as a hemostatic and sealing agent in a wide variety of applications [31][32][33][34][35][36][37][38][39][40][41][42]. A previous study has suggested the potential of fibrin sealant for successfully sealing femoral artery catheterization sites [43]. In this new study, we evaluated the effectiveness of an investigational product, specifically, fibrin sealant enhanced with collagen, Collasealt (Cohesion, Palo Alto, CA), for sealing arterial puncture sites.…”