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.