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Fibrin Sealant VH S/D · 1 trial · 4 indications
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant VH S/D | DRUG | - |
| Surgical intervention alone without Fibrin Sealant VH S/D application | PROCEDURE | - |
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 is a small molecule drug developed by Baxter International Inc. (BAX) for use in bleeding (oozing) in hepatic resection and in breast cancer, specifically to reduce lymphatic leakage by sealing axillary lymph node dissection sites. It is an investigational product that has been studied in clinical trials.
Fibrin Sealant VH S/D is a fibrin sealant that works by mimicking the final steps of the blood clotting cascade. It forms a stable fibrin clot when applied to tissue, which helps seal bleeding surfaces and prevent lymphatic leakage. The drug's mechanism is based on the action of fibrinogen and thrombin, which are its active components.
Fibrin Sealant VH S/D is developed by Baxter International Inc., a company traded on the NYSE under the ticker BAX. Baxter is responsible for the clinical development and manufacturing of this investigational fibrin sealant product.
Fibrin Sealant VH S/D has completed a Phase 3 clinical trial for breast cancer and lymphatic leakage, and a Phase 2 trial for bleeding in hepatic resection. It is not FDA approved and remains an investigational drug in clinical development.
Fibrin Sealant VH S/D has been studied in two completed trials. NCT00161980 was a Phase 3 trial in breast cancer patients undergoing lumpectomy or mastectomy with axillary lymph node dissection, conducted in Austria, France, Germany, and Italy. NCT01244425 was a Phase 2 trial in hepatic resection bleeding, conducted in Germany with 70 participants.
Yes, Fibrin Sealant VH S/D is also known as FS VH S/D, which stands for Fibrin Sealant Vapor Heated Solvent/Detergent Treated. This alternative name appears in clinical trial records and is used interchangeably with the full drug name.