RECRUITING

ACCEL Absorbable Hemostat

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ACCEL® Absorbable Hemostat Powder Clinical Trial

Quick Facts

Study Start:2021-10-26

Study Completion:2025-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04728087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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	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 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.

Inclusion Criteria

Exclusion Criteria

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
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

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
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.

Contacts and Locations

Study Contact

Aurelius D Butler, MS

CONTACT

651-621-8295

AButler@hemostasisllc.com

John Shanahan, PhD

CONTACT

651-233-2073

jshanahan@hemostasisllc.com

Study Locations (Sites)

Keck Medical Center of USC

Los Angeles, California, 90033

United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

United States

Washington University in St. Louis

Saint Louis, Missouri, 63110

United States

Washington University in St. Louis

Saint Louis, Missouri, 63110

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

University of Wisconsin - Madison

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Hemostasis, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-26

Study Completion Date2025-01-30

Study Record Updates

Study Start Date2021-10-26

Study Completion Date2025-01-30

Terms related to this study

Additional Relevant MeSH Terms

Hemostasis