GATT-Patch vs TachoSil for Liver Surgery-related Bleeding

No longer recruiting at 11 trial locations

Overseen By Ingrid Fossan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GATT Technologies BV

Must not be taking: Antithrombotics

Disqualifiers: Pregnancy, Infection, Immunodeficiency, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new hemostatic patch, GATT-Patch, compared to an existing one, TachoSil, in controlling bleeding during liver surgery. It aims to assess the safety and effectiveness of these patches when traditional methods fail to stop bleeding. The trial seeks participants scheduled for elective open liver surgery who experience minimal to moderate bleeding that cannot be controlled with standard methods like stitches or cauterizing.

As an unphased trial, this study allows patients to contribute to advancements in surgical care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those taking multiple antithrombotic therapies (blood thinners) in therapeutic doses, except for acetylsalicylic acid (aspirin). It's best to discuss your specific medications with the trial team.

What prior data suggests that these hemostatic patches are safe for liver surgery-related bleeding?

Research has shown that the GATT-Patch, used to control bleeding during liver surgery, is safe. Studies have found that this patch can stop bleeding quickly, sometimes in just 30 seconds for most patients.

No major safety problems have been reported with the GATT-Patch. It is designed to help control bleeding when other methods aren't enough. While every treatment carries some risks, evidence suggests that the GATT-Patch is well-tolerated by patients undergoing liver surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GATT-Patch, also known as ETHIZIA, because it offers a unique approach to managing bleeding during liver surgery. Unlike other hemostatic patches like TachoSil, the GATT-Patch may have a novel design or material that enhances its ability to stop bleeding more efficiently. This could lead to faster recovery times and improved surgical outcomes, making it a promising option for surgeons dealing with complex liver procedures.

What evidence suggests that this trial's treatments could be effective for liver surgery-related bleeding?

Research has shown that the GATT-Patch, which participants in this trial may receive, effectively stops bleeding during surgery. One study found that 82% of patients stopped bleeding in just 30 seconds. Another study demonstrated that the GATT-Patch stopped bleeding in all cases within 10 seconds, outperforming similar products like TachoSil. This trial will compare the effectiveness of the GATT-Patch with TachoSil for controlling bleeding in liver surgeries. ^{1 2 5 6 7}

Who Is on the Research Team?

James Guarrera

Principal Investigator

Rutgers New Jersey Medical School, Newark, NJ, USA

Hans de Wilt

Principal Investigator

Radboud University Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject has been informed of the nature of the clinical investigation

I am 22 years old or older.

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

Exclusion Criteria

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo elective open liver surgery with either GATT-Patch or TachoSil for hemostasis

During surgical procedure

1 visit (in-person)

Hospitalization

Participants are monitored during hospitalization up to discharge, including ICU stay and blood transfusions

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including liver resection surface complications

3 months

1 visit at 6 weeks, additional follow-up visits as needed

Long-term Follow-up

Participants are monitored for cancer recurrence and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• GATT-Patch
• TachoSil

Trial Overview 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.

How Is the Trial Designed?

Group I: GATT-Patch (currently named ETHIZIA) Experimental Treatment 1 Intervention

Hemostatic patch

Group II: TachoSil Active Control 1 Intervention

Hemostatic patch

Who Is Running the Clinical Trial?

GATT Technologies BV

Lead Sponsor

Trials

3

Recruited

240+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0022480424001446

Clinical Safety and Performance of GATT-Patch for ... The primary endpoint was hemostasis of the first-treated bleeding site at 3 min versus a prespecified performance goal of 65.4%.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38640617/

Clinical Safety and Performance of GATT-Patch for ... GATT-Patch was used for minimal to moderate bleeding at the liver resection plane. The primary endpoint was hemostasis of the first-treated ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05385952

GATT-Patch Versus TachoSil in Liver Surgery GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36918896/

Efficacy of a novel polyoxazoline-based hemostatic patch ... In experiment 3, GATT-Patch, Veriset™, TachoSil and GFC Blank reached hemostasis after 10s in 100%, 42.8%, 7.1% and 14.3%, respectively, and at ...

5. jnjmedtech.com jnjmedtech.com/en-EMEA/campaign/ethizia-hemostatic-sealing-patch-bleeding-controlled

ETHIZIA Hemostatic Sealing Patch - Bleeding Controlled The Full Analysis Set showed 32/39 patients (82%) achieved hemostasis in 30 seconds. B. Pre-clinical test data are not necessarily indicative of clinical ...

6. jnj.com jnj.com/media-center/press-releases/ethicon-introduces-ethiziatm-hemostatic-sealing-patch-clinically-proven-to-stop-disruptive-bleeding

Ethicon Introduces ETHIZIATM Hemostatic Sealing Patch ... In 80% of clinical trial patients studied****, ETHIZIA™ Hemostatic Sealing Patch stopped bleeding in 30 seconds, an average of six times faster ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04819945

Clinical Safety and Performance of GATT-Patch in Open ... The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.