The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study

Exclusion Criteria

• •1. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
• •2. Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing;
• •3. Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor;
• •4. Subjects who are known, current alcohol and/or drug abusers
• •5. Subjects admitted for trauma surgery
• •6. Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
• •7. Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery or scheduled to receive COVID-19 vaccine within the 30-day follow-up period
• •8. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
• •9. TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and pressure during healing and absorption of the product
• •10. TBS with major arterial bleeding requiring suture or mechanical ligation;
• •11. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.