A Single‐blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
Bleeding is a major complication during cardiovascular surgery. Various approaches have been developed to control bleeding, including the use of fibrin sealants, which are a type of tissue adhesive that can be applied at the site of bleeding to reduce blood loss and promote wound healing.
The Evarrest study is evaluating the safety and effectiveness of the Evarrest Fibrin Sealant Patch. We are recruiting patients undergoing open surgery on the aorta who experience bleeding. Patients are allocated by chance to receive either the Evarrest patch or the Tachosil patch, which is currently approved for use during cardiac surgery.
We will determine whether the Evarrest patch is better than the Tachosil patch at stopping bleeding, and whether it is safe.