GATT-Patch vs TachoSil for Liver Surgery-related Bleeding

Recruiting at 10 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

131 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment GATT-Patch and TachoSil for liver surgery-related bleeding?

Research shows that TachoSil, a patch used to stop bleeding, has been effective in reducing bleeding complications in various surgeries, including liver operations. It has been shown to meet surgeons' expectations for safety and effectiveness, and in some cases, it has helped save organs by controlling bleeding. ^{1 2 3 4 5}

Is TachoSil safe for use in surgeries?

TachoSil, a surgical patch used to control bleeding, has been studied in various surgeries and is generally considered safe. In a large study involving 408 patients, surgeons found it effective and safe, with benefits outweighing complications. It has been used in liver, heart, and other surgeries with positive safety outcomes. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

James Guarrera

Principal Investigator

Rutgers New Jersey Medical School, Newark, NJ, USA

Hans de Wilt

Principal Investigator

Radboud University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: GATT-Patch 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+

References

1. England pubmed.ncbi.nlm.nih.gov

Postoperative bleeding and biliary leak after liver resection: A cohort study between two different fibrin sealant patches. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

[Hemostatic effectiveness of TachoSil® patches in radiofrequency assisted minor hepatic resection]. [2011]

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

The use of a surgical patch coated with human coagulation factors in surgical routine: a multicenter postauthorization surveillance. [2006]

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

Effect of TachoSil in a coagulopathic pig model with blunt liver injuries. [2018]

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

Quick and Easy Application Method of TachoSil®️ During Laparoscopic and Robotic Liver Resections. [2023]