ACCEL Absorbable Hemostat

ACCEL® Absorbable Hemostat Powder Clinical Trial

The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical trial to evaluate the safety and efficacy of the ACCEL® Absorbable Hemostat Powder as compared to gelatin sponge, for achieving hemostasis in subjects undergoing cardiovascular, liver, or soft tissue surgery, when control of oozing to moderate bleeding by standard surgical techniques is ineffective and/or impractical.

Study Overview

• Status: Recruiting
• Conditions: Hemostasis
• Intervention / Treatment: Device: ACCEL® Absorbable Hemostat Powder; Device: Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurelius D Butler, MS; Phone Number: 651-621-8295; Email: AButler@hemostasisllc.com
• Study Contact Backup: Name: John Shanahan, PhD; Phone Number: 651-233-2073; Email: jshanahan@hemostasisllc.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Completed
      • Keck Medical Center of USC
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Completed
      • Saint Luke's Hospital of Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St. Louis
      • Contact: Kyle Stumbaugh; Phone Number: 314-747-0707; Email: kyles@wustl.edu
      • Principal Investigator: Puja Kachroo, MD
      • Contact: James Hermeyer; Phone Number: 314.362.3341; Email: hermeyer.j@wustl.edu
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Mariah Merriam; Phone Number: 214-645-0424; Email: Mariah.Merriam@UTSouthwestern.edu
      • Contact: Molly Sperry; Phone Number: 214-645-0445; Email: Molly.Sperry@UTSouthwestern.edu
      • Principal Investigator: Adam Yopp, MD
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin - Madison
      • Principal Investigator: Chris Rokkas, MD
      • Contact: Sydney Thompson; Phone Number: 608-263-2565; Email: thompsonsy@surgery.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACCEL; Participant will be treated with up to 2 bellows (10 grams nominal) of ACCEL®.	Device: ACCEL® Absorbable Hemostat Powder; Up to 2 bellows (10 grams nominal) of ACCEL®
Active Comparator: Gelfoam or SURGIFOAM; Participant will be treated with up to 12.5 cm x 8.0 cm of Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) or SURGIFOAM® (Absorbable Gelatin Sponge, Manufacturer Part Number ETH1974).	Device: Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01); Up to 12.5 cm x 8.0 cm of Gelfoam® or SURGIFOAM® .; Other Names: SURGIFOAM® (Absorbable Gelatin Sponge, Manufacturer Part Number ETH1974).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstration of non-inferiority	Comparison of the percentage of subjects achieving hemostasis within three (3) minutes for cardiovascular surgery and within five (5) minutes for liver surgery and soft tissue surgery of the TBS using the ACCEL® Absorbable Hemostat Powder as compared to the control hemostat.	Day 0 / Surgery
Determination of incidence of SADE and ADE	The analysis and comparison of the incidence of SADEs and ADEs through the six (6) week follow-up endpoint for the ACCEL® Absorbable Hemostat Powder and the control hemostat.	Through the six (6) week follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of TTH	A comparison of TTH (either 90 seconds or 3 minutes for cardiovascular and either 2 minutes or 5 minutes for liver surgery and soft tissue surgery) for the application of ACCEL® Absorbable Hemostat Powder and the control hemostat on the TBS.	Day 0 / Surgery
Individual subject success rate	A comparison of the proportion of individual subject successes (i.e., successful hemostasis and no SADEs and ADEs) for the application of ACCEL® Absorbable Hemostat Powder and the control hemostat on the TBS.	Through the six (6) week follow-up.
Length of individual subject hospitalization	The calculation and comparison of the number of days of individual subject hospitalization through the post-surgical (Day 1-7) follow-up endpoint for the ACCEL® Absorbable Hemostat Powder and the control hemostat.	Through the post-surgical follow-up (Day 1-7)

Collaborators and Investigators

• Sponsor: Hemostasis, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Gelatin Sponge, Absorbable
• Other Study ID Numbers: Protocol 0312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes