ACCEL Absorbable Hemostat

Hemostasis, LLC

Status: Enrolling

Conditions: Hemostasis

Treatments: Device: Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01); Device: ACCEL® Absorbable Hemostat Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT04728087

Protocol 0312

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

ACCEL

Experimental group

Description:

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

Treatment:

Device: ACCEL® Absorbable Hemostat Powder

Gelfoam or SURGIFOAM

Active Comparator group

Description:

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).

Treatment:

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