What side effects are associated with this type of intervention?

Common treatments for intraoperative blood loss using physical and biochemical means, such as fibrin sealants and gelatin granules, can have side effects including allergic reactions, infection at the application site, and delayed wound healing. Fibrin sealants, which contain plasma-derived clotting proteins, may also pose a risk of transmitting infectious agents despite screening processes. Additionally, some patients may experience local tissue irritation or inflammation. It is important to monitor for these potential complications during and after surgery.

What prior FDA approvals exist?

The FDA has approved several treatments for intraoperative blood loss that utilize physical and biochemical means. Notable examples include TachoSil, a surgical patch that combines a collagen sponge with human fibrinogen and thrombin to promote hemostasis, and various formulations of tranexamic acid, an antifibrinolytic agent used to reduce bleeding. Additionally, fibrin sealants like Evicel and Tisseel, which use a combination of fibrinogen and thrombin to form a stable clot, have been approved for surgical use. These treatments are designed to control bleeding during surgery by enhancing the body's natural clotting mechanisms.

What other types of research exist?

Promising alternatives to GATT-Patch for managing intraoperative blood loss include: 1) TachoSil, a fibrin sealant patch, which has been compared directly to GATT-Patch in clinical trials. 2) Chitosan dressings, which are being developed for their hemostatic properties. 3) Kaolin-impregnated sponges, which promote clotting. 4) Fibrin sealant dressings, which are used to control bleeding through biochemical means. These alternatives are either currently in use or have shown potential in clinical settings.

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Hemostatic Agent

GATT-Patch vs TachoSil for Liver Surgery-related Bleeding

N/A

Waitlist Available

Led By James Guarrera

Research Sponsored by GATT Technologies BV

Eligibility Criteria Checklist

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

Must have

Subject is 22 years of age or older at the time of enrollment

Subject in whom the Investigator is able to identify a target bleeding site at the liver resection plane for which any applicable conventional means for hemostasis (e.g. suture, ligature or cautery) are ineffective or impractical, and the choice is made to use a hemostatic agent to stop the bleeding

Must not have

The target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency

Subject who has religious objections to receiving products with components of animal (porcine or equine) or human origin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the GATT-Patch, a medical patch that helps control bleeding, on patients having elective open liver surgery. The patch works by promoting blood clotting when applied to the bleeding area.

Who is the study for?

This trial is for adults aged 22 or older who are scheduled for elective open liver surgery and need a hemostatic agent due to ineffective conventional bleeding control methods. Excluded are those with severe blood clotting issues, high bilirubin levels, pregnancy, hypersensitivity to certain animal proteins or dyes, infections at the bleeding site, imminent organ transplants, participation in other trials within 30 days affecting this study's endpoints.

What is being tested?

The trial compares GATT-Patch against TachoSil for safety and effectiveness in managing minimal to moderate bleeding during liver surgery. It's pre-market research involving random assignment of participants (2:1 ratio) across multiple centers internationally.

What are the potential side effects?

Potential side effects may include allergic reactions to components like porcine gelatin or horse proteins found in the patches and complications related to improper bleeding management at the surgical site.

Eligibility Criteria

Inclusion Criteria

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

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I am 22 years old or older.

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My doctor identified a bleeding site in my liver that can't be stopped with usual methods.

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I am scheduled for elective open liver surgery.

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My bleeding severity is minimal to moderate.

Exclusion Criteria

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

Select...

I need surgery for a large artery or vein injury to keep it open.

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I object to medical products from animals or humans due to my religious beliefs.

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I am scheduled for a specific liver surgery to remove part of my liver.

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I am scheduled for surgery on an organ other than the liver.

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I am undergoing surgery to donate part of my liver.

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I have or might have an infection where I'm bleeding.

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The investigational device will be used where I have a synthetic graft or patch.

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I have had or am planning to have an organ transplant.

Select...

I haven't been in another study that could affect this one in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of hemostasis at 3 minutes without rebleeding at the 10-minute time point

Secondary study objectives

Kaplan-Meier estimated distribution of time to hemostasis

Mean time to hemostasis (seconds)

Rate of subjects with hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 seconds

+2 more

Other study objectives

Amount of hemostatic material needed versus bleeding surface

Aspect of postoperative drainage

Cancer-free survival

+11 more

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: GATT-PatchExperimental Treatment1 Intervention

Hemostatic patch

Group II: TachoSilActive Control1 Intervention

Hemostatic patch

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GATT-Patch

2021

N/A

~190

0 / 13Eligibility 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

The most common treatments for intraoperative blood loss include physical methods like hemostatic patches (e.g., GATT-Patch, TachoSil) and biochemical agents such as tranexamic acid. Hemostatic patches work by providing a physical barrier to bleeding and promoting clot formation, while tranexamic acid inhibits fibrinolysis to stabilize clots. These treatments are essential for minimizing blood loss, reducing the need for transfusions, and improving surgical outcomes in intraoperative blood loss patients.

Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis.