ACCEL Absorbable Hemostat

NCT04728087 | Unknown DMC FDA Device

• 1 other identifier: Protocol 0312
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Determination of TTH

  Day 0 / Surgery

• Individual subject success rate

  Through the six (6) week follow-up.

• Length of individual subject hospitalization

  Through the post-surgical follow-up (Day 1-7)

Study Arms (2)

ACCEL

EXPERIMENTAL

Participant will be treated with up to 2 bellows (10 grams nominal) of ACCEL®.

Device: ACCEL® Absorbable Hemostat Powder

Gelfoam or SURGIFOAM

ACTIVE COMPARATOR

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)

Interventions

ACCEL® Absorbable Hemostat Powder DEVICE

Up to 2 bellows (10 grams nominal) of ACCEL®

ACCEL

Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01) DEVICE

Up to 12.5 cm x 8.0 cm of Gelfoam® or SURGIFOAM® .

Also known as: SURGIFOAM® (Absorbable Gelatin Sponge, Manufacturer Part Number ETH1974).

Gelfoam or SURGIFOAM

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-Surgery:
• Subject is greater than or equal to 22 years old
• Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure
• Subject is willing and able to provide appropriate (Institutional Review Board (IRB) approved) informed consent.
• The subject is willing and able to comply with the requirements of the protocol, including follow-up evaluations and schedule.
• The subject is willing to be treated with ACCEL® Absorbable Hemostat Powder
• The subject is willing to be treated with a commercially available absorbable gelatin sponge
• During Surgery:
• Subject has not received blood transfusions between screening and application of investigational product or commercially available absorbable gelatin sponge
• There is an estimated TBS surface area of ≤ 60 cm2
• 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
• 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
• There has been no intra-operative use of adjunct hemostat(s) on the target bleeding site identified for application of the study treatment

You may not qualify if:

• Pre-Surgery:
• The subject is pregnant (verified in a manner consistent with institution's standard of care)
• Subject is lactating
• 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
• Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition
• Subject has medical, social, or psychosocial issues that the Investigator believes could impact the subject's safety or compliance with study procedures
• Subject has a known allergy to potatoes
• Subject has a known allergy to porcine collagen/gelatin
• Subject has a religious or other objection to porcine products
• Subject is unwilling to receive blood products
• Subject has history of heparin-induced thrombocytopenia (only for cardiovascular subjects where heparin use is required)
• 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.).
• Subjects with platelets \< 100 X 109 PLT/L during screening
• 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
• Subject is unwilling or unable to return for the required follow-up after surgery

Sponsors & Collaborators

• Hemostasis, LLC: lead

Study Sites (7)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

COMPLETED

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

COMPLETED

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Interventions

Gelatin Sponge, Absorbable

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Aurelius D Butler, MS

CONTACT

651-621-8295; AButler@hemostasisllc.com

John Shanahan, PhD

CONTACT

651-233-2073; jshanahan@hemostasisllc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sealed, blinded envelopes will be provided by the Sponsor (Hemostasis LLC). The Investigator/designee only opens the randomization envelope after the subject has been deemed eligible for the study and an eligible TBS has been identified in order to reduce potential bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 28, 2021
• Study Start: October 26, 2021
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2025
• Last Updated: July 17, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)