Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fibrin Sealant VH S/D 500 s-apr · 1 trial · 1 indication
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 (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 |
Pre-Operative Inclusion Criteria: * Signed informed consent obtained from the subject before any study-related activities * Subject's age is 18 years or above * Subject will undergo planned, elective resection of at least 1 anatomical segment of the liver for any reason by laparotomy * Subject is w...
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.