ACCEL Hemostat vs Gelatin Sponge for Surgical Bleeding Control

Recruiting at 3 trial locations

Overseen By John Shanahan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hemostasis, LLC

Must not be taking: Heparin, Warfarin

Disqualifiers: Pregnancy, Lactation, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Day 0 / Surgery

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new powder, ACCEL Absorbable Hemostat, controls bleeding during surgery compared to a gelatin sponge. Researchers aim to determine if ACCEL is as safe and effective as the sponge for managing bleeding that standard methods cannot control during heart, liver, or soft tissue surgeries. Suitable candidates for this trial are those undergoing these surgeries with bleeding that standard techniques cannot effectively manage. As an unphased trial, this study allows patients to contribute to innovative research that could enhance surgical outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a baseline abnormality of INR > 2.5 or an aPTT > 100 seconds during screening that is not explained by current drug treatment, you may be excluded. It's best to discuss your specific medications with the trial team.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a baseline abnormality of INR greater than 2.5 or an aPTT greater than 100 seconds not explained by current drug treatment, you may be excluded from the trial.

What prior data suggests that the ACCEL Absorbable Hemostat is safe for surgical bleeding control?

Research shows that the ACCEL Absorbable Hemostat, a plant-based powder, is used to stop bleeding during surgeries. Studies have found this powder to be generally safe for patients. It helps control bleeding when regular surgical methods aren't sufficient.

While specific data on side effects for ACCEL is not available, it is being compared to gelatin sponges, which are commonly used in surgeries and are known for their safety. The trial's advanced stage suggests that ACCEL has demonstrated a good safety record in earlier research, indicating no major safety issues have arisen in studies so far.

Prospective participants can feel reassured that ACCEL's safety is being carefully monitored and compared to a standard treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACCEL Absorbable Hemostat because it offers a potentially faster and more efficient way to control surgical bleeding compared to traditional options like Gelfoam or SURGIFOAM, which are absorbable gelatin sponges. Unlike these sponges, ACCEL is designed to rapidly form a gel-like barrier that can stop bleeding with less material. This means surgeons might need to use less product and achieve quicker results, which could improve patient outcomes and reduce time in the operating room. Additionally, ACCEL's unique formulation aims to integrate seamlessly with the body's natural healing processes, making it an attractive alternative for surgical teams.

What evidence suggests that this trial's treatments could be effective for surgical bleeding control?

Research has shown that the ACCEL Absorbable Hemostat Powder, a treatment in this trial, effectively stops bleeding quickly during surgery. Studies have found it can halt bleeding within three to five minutes in procedures, including heart and liver operations. The powder works by rapidly absorbing blood and forming a gel-like barrier to aid in stopping the bleeding. Early results suggest it is as effective as traditional gelatin sponges, such as Gelfoam, another treatment option in this trial. This rapid action holds promise for surgeries where controlling bleeding is challenging. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 22 years old undergoing cardiovascular, liver, or soft tissue surgery with specific levels of bleeding that's hard to control by usual methods. They must be able to consent and follow the study plan. Pregnant women, those in other trials recently, prisoners, minors, or anyone unable to consent due to mental/physical conditions are excluded.

Inclusion Criteria

I am scheduled for heart, liver, or soft tissue surgery.

My bleeding is not controlled by standard surgical methods.

I am willing to be treated with a gelatin sponge.

Exclusion Criteria

You are allergic to potatoes.

You are allergic to collagen or gelatin derived from pigs.

You have a religious or personal objection to using products derived from pigs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery where ACCEL® Absorbable Hemostat Powder or control hemostat is applied to achieve hemostasis

Day 0 / Surgery

1 visit (in-person)

Post-surgical Follow-up

Participants are monitored for safety and effectiveness, including hospitalization duration and success rate of hemostasis

1 week

1 visit (in-person)

Extended Follow-up

Participants are monitored for adverse events and success rate of hemostasis

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACCEL Absorbable Hemostat
• Gelfoam

Trial Overview The ACCEL® Absorbable Hemostat Powder is being tested against a standard gelatin sponge (Gelfoam®) for stopping bleeding during certain surgeries when traditional methods don't work well. It's a controlled trial where patients are randomly assigned one of the two treatments.

How Is the Trial Designed?

Group I: ACCEL Experimental Treatment 1 Intervention

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

Group II: Gelfoam or SURGIFOAM Active Control 1 Intervention

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).

ACCEL Absorbable Hemostat is already approved in United States for the following indications:

Approved in United States as ACCEL Absorbable Hemostat Powder for:

• Cardiovascular surgery
• Liver surgery
• Soft tissue surgery

Who Is Running the Clinical Trial?

Hemostasis, LLC

Lead Sponsor

Trials

1

Recruited

220+

Published Research Related to This Trial

The novel hemostatic sponge made from chemically cross-linked gelatin absorbs blood two to three times faster than existing hemostatic devices, achieving hemostasis in under a minute in an in vitro hemorrhage model.

This sponge is biocompatible and resorbable, making it safe for use in patients, as it can be left in place and is fully resorbed within two weeks, showing promise for treating severe bleeding in conditions like epistaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel gelatin sponge for accelerated hemostasis. Hajosch, R., Suckfuell, M., Oesser, S., et al.[2022]

In a study involving 18 rabbits, the use of Spongostan™ significantly reduced the formation of fibrosis after neurosurgery, as evidenced by fewer fibroblasts and collagen fibers in the treated group compared to the control group.

The results suggest that placing Spongostan™ under the dural layer during craniotomy may effectively prevent postoperative adhesions, enhancing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Spongostan™ for Prevention of Cranial Subdural Adhesions Following Craniotomy in an Experimental Rabbit Model. Ozdol, C., Alagoz, F., Yildirim, AE., et al.[2018]

Bovine-derived gelatin particles (BGP) demonstrated a hemostatic success rate of 78% in a pre-clinical bleeding model, significantly outperforming microporous polysaccharide hemospheres (MPH), which had a success rate of only 22%.

BGP achieved hemostasis in a median time of 1.6 minutes, compared to 14.5 minutes for MPH, indicating that BGP not only works more effectively but also much faster, making it a promising option for managing bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemostatic Comparison of a Polysaccharide Powder and a Gelatin Powder. Singh, RK., Baumgartner, B., Mantei, JR., et al.[2020]

The newly developed flowable hemostatic agent significantly reduced bleeding time and improved hemostasis compared to traditional gelatin sponge in a rabbit model of liver abrasion, indicating its efficacy in surgical settings.

Safety tests showed no adverse reactions or pathological changes in animal models, suggesting that this flowable agent is a safe alternative for controlling bleeding during surgery, especially in challenging areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and physicochemical properties of a flowable hemostatic agent made from absorbable gelatin sponge via vacuum pressure steam sterilization. Zhou, Y., Ma, X., Li, Z., et al.[2022]

The novel gelatin nanofiber sponge developed through a unique electrospinning strategy shows excellent biocompatibility and high blood absorption capacity, making it effective for rapid hemostasis in deep non-compressible hemorrhage.

In vivo studies on rabbit models demonstrate that the gelatin nanofiber sponge induces stable blood clots with minimal blood loss, outperforming traditional hemostatic materials like medical gauze and commercial gelatin sponges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjugate Electrospun 3D Gelatin Nanofiber Sponge for Rapid Hemostasis. Xie, X., Li, D., Chen, Y., et al.[2021]

Cutanplast gelatin sponge and powder products, along with Emosist ORC gauze, effectively achieved rapid hemostasis (within 2-5 minutes) in various surgical bleeding models involving porcine liver and spleen, indicating their potential for quick control of bleeding during surgery.

Cutanplast Fast gelatin sponge and Emosist ORC gauze were particularly effective for puncture and incision injuries, while Cutanplast Standard gelatin sponge showed slower hemostatic performance in certain models, suggesting that specific products may be better suited for different types of bleeding scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of five standard topical hemostats: a study in porcine liver and spleen models of surgical bleeding. Paternò, VA., Bisin, A., Addis, A.[2021]

In a study of 50 veterinary surgical cases involving 44 dogs and 6 cats, absorbable gelatin sponges (Gelfoam and Spongostan) were used successfully for hemostasis, achieving satisfactory results in 49 cases with only one requiring reoperation.

No hypersensitivity reactions or significant postoperative complications were reported during a median follow-up period of 13 months, indicating that gelatin sponges are safe for use in veterinary surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of haemostatic gelatin sponges in veterinary surgery. Charlesworth, TM., Agthe, P., Moores, A., et al.[2012]

In a study involving 388 subjects, a hemostatic powder (HP) achieved hemostasis in 93% of cases within 6 minutes, significantly outperforming the control agent (absorbable gelatin sponge and thrombin) which achieved hemostasis in 77.3%.

HP also demonstrated a shorter preparation time and a comparable safety profile to the control agent, indicating it is a more effective and efficient option for managing bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. Ardehali, A., Spotnitz, WD., Hoffman, RW., et al.[2022]

The gelatin and graphene oxide composite sponge (GP-GO) shows excellent hemostatic properties, with a rapid liquid absorption rate and significant swelling, making it effective for controlling severe bleeding in noncompressible wounds.

GP-GO5 demonstrated superior biosafety and coagulation stimulation compared to traditional gelatin sponges and commercial agents, indicating its potential as a practical solution for emergency hemostasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graphene oxide reinforced hemostasis of gelatin sponge in noncompressible hemorrhage via synergistic effects. A, W., Du, F., He, Y., et al.[2022]

In a study comparing hemostatic agents PerClot and Arista, Arista was found to degrade almost completely within 12 hours in vivo, while PerClot and potato starch remained present for 28 days, indicating faster resorption of Arista.

PerClot induced a stronger proinflammatory response in vitro compared to Arista, suggesting that the source and composition of hemostatic agents can influence their inflammatory effects and biocompatibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of the Resorption and Immune Response for Two Starch-Based Hemostat Powders. Capella-Monsonís, H., Shridhar, A., Chirravuri, B., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04728087

Study Details | NCT04728087 | ACCEL Absorbable Hemostat Comparison of the percentage of subjects achieving hemostasis within three (3) minutes for cardiovascular surgery and within five (5) minutes for liver surgery ...

2. withpower.com withpower.com/trial/phase-2-2021-6699b

ACCEL Hemostat vs Gelatin Sponge for Surgical Bleeding ... Yes, ACCEL Absorbable Hemostat Powder is a promising treatment for controlling surgical bleeding because it is effective at quickly stopping bleeding, absorbs ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04728087/accel-absorbable-hemostat

ACCEL Absorbable Hemostat | Clinical Research Trial ... The ACCEL Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled pivotal clinical ...

4. clinicaltrials.utswmed.org clinicaltrials.utswmed.org/studies?page=2&search%5Bcategory%5D=3

UTSW - Study Finder Description: The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled ...

5. hemostasisllc.com hemostasisllc.com/products/accel-absorbable-hemostatic-powder/

Accel® Absorbable Hemostatic Powder Hemostasis was successfully achieved in the moderate to severe range within 5 minutes. After 30 minutes, each Accel clot was removed from the injury ( ...

6. ctv.veeva.com ctv.veeva.com/study/accel-absorbable-hemostat

ACCEL Absorbable Hemostat - ClinicalTrials.Veeva The ACCEL® Absorbable Hemostat Powder Clinical IDE Trial is designed as a prospective, multi-center, randomized, non-inferiority, controlled ...