title: Improved bleeding scores using Gelfoam(®) Powder with incremental concentrations of bovine thrombin in a swine liver lesion model.
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.
authors.affiliation: Drug Safety Research and Development, Pfizer, 445 Eastern Point Road, Groton, CT, 06355, USA. Dennis.Morse@pfizer.com.
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Morse
authors.affiliation: Pfizer, 235 E 42nd Street, New York, NY, 10017, USA.
authors.forename: Elif
authors.initials: E
authors.lastname: Silva
authors.affiliation: NAMSA, 6750 Wales Road, Northwood, OH, 43619, USA.
authors.forename: Jolee
authors.initials: J
authors.lastname: Bartrom
authors.affiliation: NAMSA, 6750 Wales Road, Northwood, OH, 43619, USA.
authors.forename: Kelli
authors.initials: K
authors.lastname: Young
authors.affiliation: NAMSA, 4050 Olson Memorial Highway, Suite 450, Minneapolis, MN, 55422, USA.
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Bass
authors.affiliation: Drug Safety Research and Development, Pfizer, 445 Eastern Point Road, Groton, CT, 06355, USA.
authors.forename: David
authors.initials: D
authors.lastname: Potter
authors.affiliation: , 921 Toledo Ave N, Golden Valley, MN, 55422, USA.
authors.forename: Trevor
authors.initials: T
authors.lastname: Bieber
mesh_terms: D000818:Animals; D002417:Cattle; D004195:Disease Models, Animal; D004305:Dose-Response Relationship, Drug; D005781:Gelatin Sponge, Absorbable / Q000494:pharmacology / Q000627:therapeutic use*; D006470:Hemorrhage / Q000175:diagnosis / Q000628:therapy*; D006490:Hemostatics / Q000494:pharmacology / Q000592:standards*; D008099:Liver / Q000293:injuries / Q000473:pathology; D013552:Swine; D013917:Thrombin / Q000008:administration & dosage / Q000494:pharmacology*; D013997:Time Factors
chemical_list: D006490:Hemostatics; D013917:Thrombin
keywords: Bleeding; Gelatin powder; Gelfoam; Hemostasis; Swine; Thrombin