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THROMBIN-JMI® (thrombin, topical, bovine origin) Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY

13.2 Animal Toxicology and/or Pharmacology

Thrombin Concentration Study

In a blinded pre-clinical study conducted on a liver lesion model in swine, an inverse dose related response was observed between the visual bleeding scores and the thrombin1 concentration within the absorbable gelatin powder delivery system (GEL-FLOW™ NT) syringe, a device containing 550 mg of absorbable gelatin powder (GELFOAM® Powder). Bleeding was assigned scores according to a visual scale, with scores of 0 (no bleeding), 0.5 (ooze), 1 (very slight), 2 (slight), 3 (moderate), and 4 (severe). Scores of 1 and less were considered clinically acceptable. The 770 IU/mL thrombin concentration provided statistically significant lower bleeding scores than either 375 IU/mL or 250 IU/mL thrombin concentrations2 (Table 1). The results of this study showed that higher concentrations of thrombin within the GEL-FLOW™ NT syringe resulted in improved hemostasis as measured by lower bleeding scores.

Table 1: Comparison of Effect on Hemostasis of Varying Thrombin Concentrations in GEL-FLOW™ NT as Measured by Bleeding Scores in Swine Liver Lesion Model
Comparison of Effect on Bleeding Scores of Varying Thrombin Concentrations in GEL-FLOW™ NT in Animal Model using Repeated Measures Logistic Regression
Parameter250 IU/mL
Mean (Standard Error)
375 IU/mL
Mean (Standard Error)
770 IU/mL
Mean (Standard Error)
*
Significantly different from both 250 and 375 IU/mL at <0.001 significance level. Tukey adjusted p-values for multiple comparisons.
Significantly different from 250 IU/mL at the 0.05 significance level. Tukey adjusted p-value for multiple comparisons.
3 Minute Bleeding Score1.8 (0.2)1.6 (0.2)0.7 (0.2)*
6 Minute Bleeding Score1.7 (0.2)1.5 (0.2)0.6 (0.2)*
9 Minute Bleeding Score1.5 (0.2)1.2 (0.2)0.5 (0.2)*
12 Minute Bleeding Score1.4 (0.2)1.0 (0.2)0.4 (0.2)*

1
THROMBIN-JMI (Thrombin, Topical (Bovine) USP) was used for all thrombin concentrations tested in this study.
2
Per the THROMBIN-JMI prescribing information, for routine use THROMBIN-JMI is reconstituted with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 International Units per mL.

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