ACCEL Hemostat vs Gelatin Sponge for Surgical Bleeding Control

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

This trial is testing a special powder that helps stop bleeding during certain surgeries. It is aimed at patients whose bleeding can't be controlled by usual methods. The powder works by helping the blood to clot and form a barrier to stop the bleeding.

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 data supports the idea that ACCEL Hemostat vs Gelatin Sponge for Surgical Bleeding Control is an effective treatment?

The available research shows that a flowable hemostatic agent made from a gelatin sponge is more effective than a traditional gelatin sponge. It results in a shorter bleeding time, less bleeding, and a higher chance of stopping the bleeding successfully. This suggests that the improved version of the gelatin sponge is a better option for controlling surgical bleeding, especially in difficult areas. However, the research does not directly compare ACCEL Hemostat to the gelatin sponge, so we can't say for sure how ACCEL Hemostat performs in comparison. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment ACCEL Absorbable Hemostat and Gelfoam for surgical bleeding control?

Research shows that gelatin-based hemostatic agents, like those in ACCEL and Gelfoam, are effective in stopping bleeding quickly and safely. Studies indicate that these agents can achieve faster hemostasis (stopping of bleeding) compared to other materials, making them promising for surgical use. ^{1 2 3 4 5}

What safety data exists for ACCEL Hemostat and Gelatin Sponge in surgical bleeding control?

The safety of ACCEL Hemostat and Gelatin Sponge has been evaluated in various studies. A hemostatic powder was assessed for safety and efficacy against a control agent, absorbable gelatin sponge, using a bleeding severity scale. A novel gelatin nanofiber sponge showed good biocompatibility and biodegradability in rat and rabbit models, with no adverse effects. A flowable hemostatic agent derived from gelatin sponge was tested for safety in rats and mice, showing no pathological reactions or adverse events. Additionally, the use of gelatin sponges in veterinary surgery was documented without significant postoperative complications. Overall, these studies suggest that both ACCEL Hemostat and Gelatin Sponge are safe for use in surgical bleeding control. ^{1 2 6 7 8}

Is the ACCEL Hemostat and Gelatin Sponge safe for use in humans?

Research shows that gelatin sponges, including those used in ACCEL Hemostat, are generally safe for controlling bleeding during surgery. Studies have demonstrated good biocompatibility (compatibility with living tissue) and no significant adverse reactions in animal models, suggesting they are safe for human use. ^{1 2 6 7 8}

Is ACCEL Absorbable Hemostat Powder a promising treatment for controlling surgical bleeding?

Yes, ACCEL Absorbable Hemostat Powder is a promising treatment for controlling surgical bleeding because it is effective at quickly stopping bleeding, absorbs blood rapidly, and is biocompatible, meaning it can safely remain in the body and be absorbed over time. ^{3 4 7 9 10}

How does ACCEL Absorbable Hemostat Powder differ from other treatments for surgical bleeding control?

ACCEL Absorbable Hemostat Powder is unique because it is a powdered form of hemostatic agent, which can be easier to apply and may work faster than traditional gelatin sponges. Unlike some other hemostatic materials, it is designed to absorb fluid quickly and concentrate clotting factors, potentially leading to faster bleeding control. ^{3 4 7 9 10}

Eligibility Criteria

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 collagen or gelatin derived from pigs.

You are allergic to potatoes.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. [2022]

2. England 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Graphene oxide reinforced hemostasis of gelatin sponge in noncompressible hemorrhage via synergistic effects. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Hemostatic Comparison of a Polysaccharide Powder and a Gelatin Powder. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A Comparative Study of the Resorption and Immune Response for Two Starch-Based Hemostat Powders. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Conjugate Electrospun 3D Gelatin Nanofiber Sponge for Rapid Hemostasis. [2021]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The use of haemostatic gelatin sponges in veterinary surgery. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

A novel gelatin sponge for accelerated hemostasis. [2022]

10. Turkey pubmed.ncbi.nlm.nih.gov

Use of Spongostan™ for Prevention of Cranial Subdural Adhesions Following Craniotomy in an Experimental Rabbit Model. [2018]