Improved bleeding scores using Gelfoam(®) Powder with incremental concentrations of bovine thrombin in a swine liver lesion model.

Dennis C Morse,David Potter,Eric J Bass,Trevor Bieber,Kelli Young,Jolee Bartrom,Elif Silva

doi:10.1007/s11239-016-1388-6

Abstract

Topical hemostatic agents are used intra-operatively to prevent uncontrolled bleeding. Gelfoam® Powder contains a hemostatic agent prepared from purified pork skin gelatin, the efficacy of which is increased when combined with thrombin. However, the effect of increasing concentrations of thrombin on resultant hemostasis is not known. This study sought to evaluate the ability of various concentrations of thrombin in combination with Gelfoam Powder to control bleeding using a swine liver lesion model. Ten pigs underwent a midline laparotomy. Circular lesions were created in the left medial, right medial, and left lateral lobes; six lesions per lobe. Gelfoam Powder was hydrated with Thrombin–JMI® diluted to 250, 375, and 770 IU/mL. Each concentration was applied to two lesion sites per lobe. Bleeding scores were measured at 3, 6, 9, and 12 min using a 6-point system; comparison of bleeding scores was performed using ANOVA with the post hoc Tukey test. The bleeding scores with thrombin concentrations at 770 IU/mL were significantly lower than at 250 and 375 IU/mL at all four time points. The percentage of biopsies with a clinically acceptable bleeding score rose from 37.9, 46.6, and 71.2 % at 3 min to 55.2, 69.0, and 88.1 % at 12 min in the 250, 375, and 770 IU/mL thrombin groups, respectively. The study showed that the hemostatic response to thrombin was dose-related: using higher concentrations of thrombin with Gelfoam Powder yielded improved hemostasis, as determined by lower bleeding scores.

Highlights

Maintenance of hemostasis represents a challenge in all surgical procedures
Fifty-eight lesion sites were tested with the to yield final concentrations of 250 IU/mL (T250) and T375 concentrations and 59 lesion sites were tested with the T770 concentration, all distributed evenly across all animals and each of the three liver lobes tested
The aim of this study was to investigate the effect of increasing concentrations of bovine thrombin in combination with Gelfoam Powder on resultant hemostasis using a swine liver lesion model

Summary

Introduction

Maintenance of hemostasis represents a challenge in all surgical procedures. a degree of bleeding is commonplace during any surgery, untreated or uncontrolled bleeding can lead to hematoma, infection, repeat surgery, blood transfusion, tissue/organ damage, secondary morbidities, and mortality [1].Several mechanisms are used to overcome bleeding during surgery, including direct pressure or pressure dressing, electrocautery, sutures, and ligatures. Maintenance of hemostasis represents a challenge in all surgical procedures. A degree of bleeding is commonplace during any surgery, untreated or uncontrolled bleeding can lead to hematoma, infection, repeat surgery, blood transfusion, tissue/organ damage, secondary morbidities, and mortality [1]. Topical hemostatic agents are highly useful intra-operative interventions; these can be divided into three groups: (1) hemostats, which clot blood, e.g., thrombin; (2) sealants, which prevent leakage, e.g., fibrin sealant; and (3) adhesives, which stick tissues together [2]. Thrombin is a coagulation protein that is available as an active biological hemostatic agent from bovine, human, or recombinant (human) sources. Thrombin activates platelets and converts soluble fibrinogen into insoluble fibrin, providing a lattice for platelet aggregation and thrombus formation [3].

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