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Fibrin Sealant VH S/D 500 s-apr · 2 trials · 5 indications
Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression. The following were regarded as treatment failures: * No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the "time to hemostasis" was used; a time window of +5 seconds was acceptable for showing a success) * Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required * Reapplication of FS VH S/D 500 s-apr after 4 minutes * Intraoperative rebleeding after the first 4 minutes of the observation period
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | EXPERIMENTAL | Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. |
| Manual compression - Control | ACTIVE_COMPARATOR | A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. |
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant VH S/D | DRUG | - |
| Surgical intervention alone without Fibrin Sealant VH S/D application | PROCEDURE | - |
| Fibrin Sealant (FS) VH S/D 500 s-apr | DRUG | Dosage form: spray application; dosage frequency: single application |
| Manual compression | OTHER | Dosage form: surgical gauze swab; dosage frequency: single application |
Inclusion Criteria: * Written informed consent has been obtained from the subject prior to FS VH S/D administration * Female subjects \>= 19 years of age * Subjects with breast cancer scheduled to undergo lumpectomy of the breast and level I and II axillary lymphadenectomy with two separate incisio...
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Fibrin Sealant VH S/D 500 s-apr is an investigational biologic developed by Baxter International Inc. (BAX) for surgical bleeding control. It is being studied in hepatic resection for oozing bleeding and in breast cancer surgery to reduce lymphatic leakage after axillary lymph node dissection. It is not yet approved and remains in clinical development.
Fibrin Sealant VH S/D 500 s-apr is being evaluated for two surgical indications: controlling oozing bleeding during hepatic resection and reducing lymphatic leakage after axillary lymph node dissection in breast cancer surgery. Both uses are investigational and have been studied in completed clinical trials.
Fibrin Sealant VH S/D 500 s-apr is developed by Baxter International Inc., which trades on the New York Stock Exchange under the ticker BAX. Baxter is the sponsor of the clinical trials evaluating this fibrin sealant product.
Fibrin Sealant VH S/D 500 s-apr is in Phase 2 development. A Phase 2 trial in hepatic resection has been completed, and a Phase 3 trial in breast cancer surgery has also been completed. The drug is investigational and has not been approved by the FDA.
Fibrin Sealant VH S/D 500 s-apr has been studied in two completed trials. NCT01244425 was a Phase 2 trial in hepatic resection bleeding conducted in Germany with 70 patients. NCT00161980 was a Phase 3 trial evaluating the sealant for reducing lymphatic leakage after axillary lymph node dissection in breast cancer surgery across Austria, France, Germany, and Italy.