Evaluating a new hemostatic powder for surgical bleeding control

ACCEL® Absorbable Hemostat Powder Clinical Trial

This study is testing a new powder to see if it can help control bleeding during surgeries better than the standard sponge currently used.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Hemostasis, LLC (industry)
• Locations: 7 sites (Los Angeles, California and 6 other locations)
• Trial ID: NCT04728087 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the ACCEL® Absorbable Hemostat Powder in comparison to a standard gelatin sponge for controlling bleeding during cardiovascular, liver, or soft tissue surgeries. It is a prospective, multi-center, randomized, non-inferiority trial, meaning it will determine if the new hemostatic powder is at least as effective as the existing treatment. Participants will be monitored for their response to the treatment during surgery and follow-up evaluations will be conducted to ensure compliance with the protocol. The trial seeks to provide a solution for cases where traditional surgical techniques fail to control bleeding effectively.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older undergoing specific surgical procedures where bleeding control is challenging.

Not a fit: Patients who have received blood transfusions prior to the application of the hemostatic products may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for controlling surgical bleeding, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using absorbable hemostatic agents, but this specific approach is being evaluated for the first time in this context.

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.

Where this trial is running

Los Angeles, California and 6 other locations

• Keck Medical Center of USC — Los Angeles, California, United States (COMPLETED)
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (COMPLETED)
• Washington University in St. Louis — Saint Louis, Missouri, United States (RECRUITING)
• Washington University in St. Louis — Saint Louis, Missouri, United States (RECRUITING)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
• University of Wisconsin - Madison — Madison, Wisconsin, United States (RECRUITING)

Study contacts

• Study coordinator: Aurelius D Butler, MS

Conditions: Hemostasis