HEMOBLAST Pivotal Clinical Investigation

Inclusion Criteria: * • Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery; * Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation; * Subject undergoing cardiothoracic surgery is not allergic to protamine; and * Subject is 21 years of age or older. Exclusion Criteria: * • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure; * Subject is undergoing a neurologic surgical procedure; * Subject is undergoing a spinal surgical procedure; * Subject is undergoing an emergency surgical procedure; * Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; * Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery; * Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery; * Subject receiving antiplatelet medications within 5 days prior to surgery; * Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery; * Subject has an active or suspected infection at the surgical site; * Subject has had or has planned to receive any organ transplantation; * Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent; * Subject has ASA classification of 5; * Subject has a life expectancy of less than 3 months; * Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study; * Subject has a documented severe congenital or acquired immunodeficiency; * Subject has religious or other objections to porcine, bovine, or human components; * Subject in whom the investigational or control device will be used at the site of a valve replacement or repair; * Subject in whom the investigational or control device will be used at the site of a synthetic graft or patch implant; * Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and * Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator. Intraoperative Eligibility Criteria: * Subject does not have an active or suspected infection at the surgical site; * Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment; * Subject in whom the Investigator is able to identify a TBS for which any applicable conventional means for hemostasis are ineffective or impractical; and * Subject has a TBS with an SBSS score of 1, 2, or 3.