ACCEL Absorbable Hemostat

Eligibility Criteria

• 1. Subject is greater than or equal to 22 years old
• 2. Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure
• 3. Subject is willing and able to provide appropriate (Institutional Review Board (IRB) approved) informed consent.
• 4. The subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule.
• 5. The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
• 6. The subject is willing to be treated with a commercially available absorbable gelatin sponge
• 7. Subject has not received blood transfusions between screening and application of investigational product or commercially available absorbable gelatin sponge
• 8. There is an estimated TBS surface area of ≤ 60 cm2
• 9. Visual observation of oozing (0.01 g/10s ˂ Flow ˂ 0.04 g/10s), mild (0.04 g/10s ≤ Flow ˂ 0.32 g/10s), or moderate (0.32 g/10s ≤ Flow ˂ 1.01 g/10s) bleeding as validated and when control by conventional surgical techniques, including but not limited to suture, ligature and cautery, is ineffective and/or impractical
• 10. There is an absence of intra-operative complications other than bleeding, which, in the opinion of the Investigator, may interfere with the assessment of efficacy or safety
• 11. There has been no intra-operative use of adjunct hemostat(s) on the target bleeding site identified for application of the study treatment
• 1. The subject is pregnant (verified in a manner consistent with institution's standard of care)
• 2. Subject is lactating
• 3. Subject is currently participating in another investigational device or drug trial or has participated in one in the past 4 weeks (prior to surgery) or is planning to participate in another research study involving any investigational product within 4 weeks after surgery
• 4. Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
• 5. Subject has medical, social, or psychosocial issues that the Investigator believes could impact the subject's safety or compliance with study procedures
• 6. Subject has a known allergy to potatoes
• 7. Subject has a known allergy to porcine collagen/gelatin
• 8. Subject has a religious or other objection to porcine products
• 9. Subject is unwilling to receive blood products
• 10. Subject has history of heparin-induced thrombocytopenia (only for cardiovascular subjects where heparin use is required)
• 11. Subject with a baseline abnormality of INR \> 2.5 or an aPTT\> 100 seconds during screening that is not explained by current drug treatment (e.g. heparin, warfarin, etc.).
• 12. Subjects with platelets \< 100 X 109 PLT/L during screening
• 13. Subject with Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) \> 3 X upper limit normal range during screening, except for subjects undergoing liver resection surgery or with a diagnosis of liver metastases where there is no upper limit normal for these analytes due to the nature of their disease
• 14. Subject is unwilling or unable to return for the required follow-up after surgery
• 15. Subject has an operative bleeding site which the surgeon is unable or unwilling to control with a hemostatic agent
• 16. Extracorporeal cardiopulmonary bypass circuits or blood salvage circuits are to be used during or after identification of the TBS.
• 17. There has been intra-operative use of thrombin on the patient.