Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models

Abstract

Blood loss during hepatic surgery leads to poor patient outcomes. This study investigates the hemostatic efficacy of a novel sealing hemostatic pad (polyethylene glycol-coated collagen, PCC) and a fibrin sealant pad (fibrin-thrombin coated collagen, FTC) in a leporine hepatic segmentectomy and a porcine hepatic abrasion model. A segmentectomy was used to compare hemostatic success and hematoma incidence in 20 rabbits (10/group). Hepatic abrasions were used to compare hemostatic success up to 10 min after application in six pigs (42 lesions/group). In the segmentectomy model, PCC achieved 100% hemostatic success within 2 min (95% CI: 72.3% to 100%) and FTC achieved 80% hemostatic success within 3 min (49.0% to 94.3%). PCC had lower hematoma incidence at 15 min (0.0 versus 11.1%) and 24 h (20.0 versus 66.7%). In the abrasion model, PCC provided superior hemostatic success at 3 (odds ratio: 24.8, 95% CI: 8.86 to 69.2, P < 0.001), 5 (66.3, 28.5 to 153.9, P < 0.001), 7 (177.5, 64.4 to 489.1, P < 0.001), and 10 min (777.6, 148.2 to 4078, P < 0.001) leading to statistically significant less blood loss. The novel sealing hemostat provides faster and more sustained hemostasis than a fibrin sealant pad in a leporine hepatic segmentectomy and a porcine hepatic abrasion model of hepatic surgery.

Figures

Figure 1

Hemopatch [sealing hemostat] is a pentaerythritol polyethylene glycol ether tetrasuccinimidyl glutarate (NHS-PEG) coated bovine collagen pad (a). TachoSil [absorbable fibrin sealant patch] is a human-derived fibrinogen and thrombin coated equine collagen pad (b). Insets demonstrate flexibility of each when manipulated.

Figure 2

Kaplan-Meier plot for interval censored time of hemostasis of Hemopatch and TachoSil, where the time interval during which hemostasis occurred is shaded. Hemopatch, approximated for 2 min, achieved immediate hemostasis in 100% (95% CI: 72.3% to 100%) of applications; while TachoSil, approximated for 3 min, achieved immediate hemostasis in 80% (95% CI: 49.0% to 94.3%) of applications. One TachoSil-treated animal did not achieve hemostasis within the 15-minute observational period.

Figure 3

Calculated probability of hemostatic effectiveness (black) and corresponding bootstrap-type two-sided 95% confidence intervals (gray) for hemostatic success over time with Hemopatch (solid lines) and TachoSil (dashed lines) at the median bleeding rate.

Figure 4

Odds ratio of hemostatic success and 95% confidence interval obtained from the generalized linear mixed effects model, where the odds ratio of hemostatic success of Hemopatch is divided by that of TachoSil. Hemopatch had a statistically significantly, at the 5% level, superior hemostatic success over time as the lower 95% confidence limit is greater than one.

Figure 5

Difference in rate of blood loss from lesions treated with Hemopatch and those treated with TachoSil obtained from the linear mixed effects model, where the bleeding rate of TachoSil is subtracted from that of Hemopatch. Hemopatch had a statistically significant, at the 5% level, less bleeding rate over time as the upper 95% confidence limit is less than zero.