Evarrest

Introduction

Bleeding during surgical procedures may manifest in many forms. It can be discrete or diffuse from a large surface area. It can be from large or small vessels; arterial (high pressure) or venous (low pressure) of high or low volume. It may be easily accessible or it may originate from difficult to access sites. The bleeding tissues may be firm or friable. For challenging severe bleeding, immediate control may be necessary to avoid unwanted hemodynamic consequences. In cardiovascular surgery, perioperative bleeding is a major risk as it involves joining of vascular structures with sutures (an anastomosis) in the presence of higher pressuresii,iii.

Conventional methods to achieve hemostasis include use of surgical techniques, sutures, ligatures or clips, and energy‐based coagulation or cauterization. When these conventional measures are ineffective or impractical, adjunctive hemostasis techniques and products are typically utilized, including topical absorbable hemostats such as oxidized regenerated cellulose, gelatin, or collagen and active hemostats such as topical thrombin or fibrin sealantsi.

Fibrin sealants are typically dual component systems consisting of virus‐inactivated, human plasma‐derived thrombin and fibrinogen. The two components are mixed during application to a target site and upon combination mimic the final step in the coagulation pathway to form a stable, physiological fibrin clot that assists in healingi. The fibrinogen component may also contain anti‐fibrinolytic agents. Fibrin sealants have proven to be valuable adjuncts for hemostasis in a variety of surgical and endoscopic procedures. They have been successfully used as biodegradable tissue adhesives for hemostasis, wound healing, or tissue sealing purposes in cardiovascular, thoracic, neurologic, gastrointestinal, urologic, gynecologic, hepatic and plastic and reconstructive surgical proceduresiv,v,vi,vii,viii . They have also been evaluated in bleeding from soft tissue tumor beds following surgical resectionix. Fibrin sealants have been shown to reduce post‐operative complications, including blood loss and reduce the need for repeated procedures by promoting wound healingx.

While fibrin sealants have proven efficacious in cardiovascular surgery in controlling slowly bleeding foci, diffuse oozing, and bleeding from needle puncture sites, they are not as effective in the control of more active bleedingxi,xii. There is a clinical need in cardiovascular surgery for a product which can rapidly control challenging active bleeding when treatment with conventional surgical techniques or conventional adjunctive hemostatic products is either ineffective or impractical. Hemostasis at suture holes in synthetic grafts requires a hemostatic process independent of tissue effects, a situation that is ideal for study of the hemostatic effectiveness of an adjunctive hemostatic agent in the setting of difficult to control suture hole bleeding. Further, the synthetic graft anastomosis provides a consistent model for hemostasis assessment across a range of patients. The ideal agent would be effective in a wet field with active bleeding, act independently of the patients coagulation status, rapidly and effectively control challenging bleeding of high or low pressure, and would afford ease of operative handling and storage.

Study Objectives

The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis in cardiovascular surgery.

The primary endpoint will be hemostasis at the TBS at 3‐minutes following treatment application and with no re‐bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure. Hemostasis is defined as no detectable bleeding at the TBS.

The secondary endpoints of the study include:

‐ Hemostasis at the TBS at 6 minutes following treatment application and with no re‐bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure.

‐ Hemostasis at the TBS at 10 minutes following treatment application and with no re‐bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure.

‐ Incidence of re‐bleeding requiring treatment after initial establishment of TBS hemostasis at 3 minutes.

‐ Incidence of adverse events.

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