ACCEL Absorbable Hemostat

Hemostasis Clinical Trial

Official title:

ACCEL® Absorbable Hemostat Powder Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728087
• Other study ID #: Protocol 0312
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Hemostasis, LLC
• Contact: Aurelius D Butler, MS
• Phone: 651-621-8295
• Email: AButler[@]hemostasisllc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: June 30, 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemostasis

Intervention

Device:
• ACCEL® Absorbable Hemostat Powder
Up to 2 bellows (10 grams nominal) of ACCEL®
• Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)
Up to 12.5 cm x 8.0 cm of Gelfoam® or SURGIFOAM® .

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Hemostasis, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.
Secondary	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)