THROMBIN-JMI® Nonclinical Toxicology

(thrombin, topical, bovine origin)

13 NONCLINICAL TOXICOLOGY

     

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been undertaken examining carcinogenicity, genetic toxicity or fertility.

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).1 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 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 Score

1.8 (0.2)

1.6 (0.2)

0.7 (0.2)*

6 Minute Bleeding Score

1.7 (0.2)

1.5 (0.2)

0.6 (0.2)*

9 Minute Bleeding Score

1.5 (0.2)

1.2 (0.2)

0.5 (0.2)*

12 Minute Bleeding Score

1.4 (0.2)

1.0 (0.2)

0.4 (0.2)*


1
THROMBIN-JMI (Thrombin, Topical (Bovine) U.S.P.) 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 IU per mL.

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Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY

     

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been undertaken examining carcinogenicity, genetic toxicity or fertility.

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).1 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 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 Score

1.8 (0.2)

1.6 (0.2)

0.7 (0.2)*

6 Minute Bleeding Score

1.7 (0.2)

1.5 (0.2)

0.6 (0.2)*

9 Minute Bleeding Score

1.5 (0.2)

1.2 (0.2)

0.5 (0.2)*

12 Minute Bleeding Score

1.4 (0.2)

1.0 (0.2)

0.4 (0.2)*


1
THROMBIN-JMI (Thrombin, Topical (Bovine) U.S.P.) 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 IU per mL.
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