ACCEL Absorbable Hemostat

Launched by HEMOSTASIS, LLC · Jan 25, 2021

Keywords

ClinConnect Summary

The ACCEL® Absorbable Hemostat Powder Clinical Trial is studying a new powder designed to help stop bleeding during surgeries, particularly for heart, liver, or soft tissue procedures. This trial compares the ACCEL® powder to a standard treatment called a gelatin sponge to see which is more effective in controlling bleeding when regular methods, like stitches or cauterization, aren’t enough. The trial is currently looking for participants who are at least 22 years old and are scheduled for one of these types of surgeries, and they must be willing to follow the study’s guidelines and attend follow-up appointments.

Participants in this trial can expect to receive either the new ACCEL® powder or the gelatin sponge during their surgery. To be eligible, they should not have had a blood transfusion right before the surgery and should not have any allergies to the components of the treatments being tested. It’s important for potential participants to know that they will be closely monitored during and after their surgery to ensure their safety and to gather information about how well the treatments work.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Pre-Surgery:
• • 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
• During Surgery:
• • 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
• Exclusion Criteria:
• Pre-Surgery:
• • 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
• During 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.