What side effects are associated with this type of intervention?

Common treatments for hemostasis, such as gelatin sponges and other hemostatic agents, are generally used to control bleeding when standard surgical techniques are ineffective. Known side effects of these treatments can include localized infection, allergic reactions, and delayed wound healing. In some cases, there may be a risk of excessive clotting, which could lead to complications such as thrombosis. It is important for patients to discuss these potential risks with their healthcare provider to ensure the most appropriate and safe use of hemostatic agents.

What prior FDA approvals exist?

The FDA has approved several treatments for hemostasis that promote blood clotting to control bleeding. Gelatin sponges, such as Gelfoam, are commonly used and work by providing a physical matrix that facilitates clot formation. Other absorbable hemostatic agents include oxidized regenerated cellulose (Surgicel) and thrombin-based products (Thrombin-JMI). These agents are used in various surgical settings to control oozing to moderate bleeding when standard techniques are ineffective or impractical. The ACCEL® Absorbable Hemostat Powder is being studied as a potential alternative to these established treatments.

What other types of research exist?

Promising alternatives to ACCEL® Absorbable Hemostat Powder for hemostasis include: 1) Tranexamic Acid, which can be used topically or intravenously to reduce blood loss in surgeries such as total knee arthroplasty. 2) Recombinant Factor IX products like rFIXFc for hemophilia B patients, which have shown prolonged activity and safety in clinical trials. 3) Fibrin glue, which has been effective in reducing postoperative blood loss in various surgical procedures. These alternatives have demonstrated efficacy in clinical settings and may be considered for treatment in 2024.

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Hemostatic Agent

ACCEL Hemostat vs Gelatin Sponge for Surgical Bleeding Control

N/A

Recruiting

Research Sponsored by Hemostasis, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is undergoing a cardiovascular surgery, liver surgery or soft tissue surgical procedure

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

Must not have

Subject has an operative bleeding site which the surgeon is unable or unwilling to control with a hemostatic agent

Subject is a prisoner, a minor or unable to adequately give informed consent due to mental or physical condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the post-surgical follow-up (day 1-7)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions if sensitive to potato-based products or porcine collagen/gelatin used in these hemostatic agents. Other risks could relate to the general use of hemostats such as failure to stop bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My bleeding is not controlled by standard surgical methods.

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I am willing to be treated with a gelatin sponge.

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I am willing to use ACCEL® Absorbable Hemostat Powder for treatment.

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I am 22 years old or older.

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My burn affects an area of 60 cm2 or less.

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No blood clotting agents were used on my bleeding site during surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My surgeon cannot stop my bleeding with usual methods.

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I am not a prisoner, under 18, or unable to consent due to mental or physical conditions.

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My blood takes longer to clot and it's not because of my medications.

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I cannot commit to follow-up visits after surgery.

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Thrombin was used during my surgery.

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I am not currently in, nor have I been in the last 4 weeks, any drug or device trials, and I don't plan to join one within 4 weeks after surgery.

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I am unwilling to receive blood transfusions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the post-surgical follow-up (day 1-7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the post-surgical follow-up (day 1-7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the post-surgical follow-up (day 1-7) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Demonstration of non-inferiority

Determination of incidence of SADE and ADE

Secondary study objectives

Determination of TTH

Individual subject success rate

Length of individual subject hospitalization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACCELExperimental Treatment1 Intervention

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

Group II: Gelfoam or SURGIFOAMActive Control1 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).

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hemostasis, such as the ACCEL® Absorbable Hemostat Powder, work by providing a physical matrix that promotes platelet aggregation and stabilizes blood clot formation. This mechanism is essential for hemostasis patients as it helps to quickly control bleeding when standard surgical techniques are ineffective or impractical, thereby reducing blood loss and improving surgical outcomes.

Design and assessment of clinical trials on continuous infusion.Prothrombin complex concentrate for vitamin K antagonist reversal in acute bleeding settings: efficacy and safety.