No studies have been undertaken examining carcinogenicity, genetic toxicity or fertility.
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.
| Parameter | 250 IU/mL Mean (Standard Error) | 375 IU/mL Mean (Standard Error) | 770 IU/mL Mean (Standard Error) |
|---|---|---|---|
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)* |
No studies have been undertaken examining carcinogenicity, genetic toxicity or fertility.
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.
| Parameter | 250 IU/mL Mean (Standard Error) | 375 IU/mL Mean (Standard Error) | 770 IU/mL Mean (Standard Error) |
|---|---|---|---|
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)* |
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