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Fibrin Sealant · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Fibrin Sealant | DRUG | - |
Inclusion Criteria: Included in the study were patients with proven bleeding from esophageal varices due to liver cirrhosis: * with a minimum age of 18 years, * with bleeding symptoms (hematemesis, melena, hematochezia, hypotension, tachycardia) that had lasted not longer than 48 hours prior to ho...
Fibrin Sealant is used for esophageal and/or gastric varices and deep partial or full thickness wounds. In clinical trials, it has been studied for adhering split thickness skin grafts and improving wound healing in burn patients, as well as for endoscopic injection to treat bleeding esophageal varices.
Fibrin Sealant is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker BAX.
Fibrin Sealant is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA based on the available information. Two Phase 3 trials have been completed.
Fibrin Sealant has been studied in two completed Phase 3 trials. NCT00157131 evaluated its safety and efficacy in adhering split thickness skin grafts in burn patients with deep partial or full thickness wounds. NCT00161915 compared endoscopic injection of fibrin sealant versus endoscopic ligature for bleeding esophageal varices.
Fibrin Sealant is a small molecule therapeutic. It works by mimicking the final step of the blood coagulation cascade, forming a fibrin clot that adheres to tissues and promotes hemostasis and wound healing. This mechanism is relevant for its use in variceal bleeding and wound closure.