Clinical trial NCT04728087: ACCEL Absorbable Hemostat
Official title: ACCEL® Absorbable Hemostat Powder Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemostasis
Lead sponsor: Hemostasis, LLC
Sponsor class: INDUSTRY
First posted: 2021-01-28
Enrollment: 216
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Demonstration of non-inferiority
timeFrame: Day 0 / Surgery
measure: Determination of incidence of SADE and ADE
timeFrame: Through the six (6) week follow-up.
Secondary outcomes:
measure: Determination of TTH
timeFrame: Day 0 / Surgery
measure: Individual subject success rate
timeFrame: Through the six (6) week follow-up.
measure: Length of individual subject hospitalization
timeFrame: Through the post-surgical follow-up (Day 1-7)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
References: