GATT-Patch Versus TachoSil in Liver Surgery

NCT05385952 | Completed Results DMC FDA Device

• 1 other identifier: DHF-01-SFT-194
• Study Type: interventional
• Target: 132
• Locations: 3 countries
• Sites: 10

Brief Summary

This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with TachoSil for the management of minimal, mild, or moderate bleeding during elective open liver surgery.

Conditions

Intraoperative Bleeding; Hemorrhage, Surgical; Liver Diseases

Keywords

Hemostatic patch; GATT-Patch; TachoSil; Liver surgery; Hemostasis

Outcome Measures

Primary Outcomes (1)

• Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point

  Surface Bleeding Severity Scale 0

  During surgical procedure, assessed up to 10 minutes after device application

Secondary Outcomes (5)

• Mean Time to Hemostasis (Seconds)

  During surgical procedure, assessed up to 10 minutes or up to the time that hemostasis is achieved, whichever occurred last

• Kaplan-Meier Estimated Distribution of Time to Hemostasis

  During surgical procedure, up to the time that hemostasis is achieved

• Rate of Subjects With Treatment Failure

  During surgical procedure

• Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure

  During surgical procedure up to patient closure

• Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds

  During surgical procedure up to 10 minutes after device application

Other Outcomes (15)

• Procedure Duration

  During surgical procedure

• Estimated Blood Loss

  During surgical procedure

• Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma

  During surgical procedure

Study Arms (2)

GATT-Patch (currently named ETHIZIA)

EXPERIMENTAL

Hemostatic patch

Device: GATT-Patch (currently named ETHIZIA)

TachoSil

ACTIVE COMPARATOR

Hemostatic patch

Drug: TachoSil

Interventions

GATT-Patch (currently named ETHIZIA) DEVICE

GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location. 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 surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.

GATT-Patch (currently named ETHIZIA)

TachoSil DRUG

TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

TachoSil

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is scheduled to undergo elective open surgery on the liver;
• Subject is willing and able to give written informed consent for the clinical investigation participation;
• Subjects is 22 years of age or older at the time of enrollment; and
• Subject has been informed of the nature of the clinical investigation.
• 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; and
• Subject has a target bleeding site with a SBSS of 1, 2, or 3 (e.g. reflecting minimal, mild or moderate bleeding severities).

You may not qualify if:

• The target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency;
• Subject is scheduled to undergo surgery on other organs than the liver and its associated biliary and vascular system; • Subject is scheduled to undergo a staged liver surgery procedure (e.g., Associating Liver Partition and Portal vein ligation for Staged hepatectomy \[ALPPS\])
• Subject is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid;
• Subject has platelet count \<100 x 109/L, an activated partial thrombin time of \>100s, or international normalized ratio \>2.5;
• Subject has a total bilirubin level of ≥2.5 mg/dl;
• Subject is pregnant, planning on becoming pregnant or actively breastfeeding during the 3-month follow-up period;
• Subject has a known hypersensitivity to brilliant blue (FD\&C Blue #1), porcine gelatin, or horse proteins;
• Subject who has religious objections to receiving products with components of animal (porcine or equine) or human origin;
• Subject has an active or suspected infection at the bleeding site;
• Subject in whom the investigational device will be used at the site of a synthetic graft or patch implant;
• Subject has a life expectancy of less than 3 months;
• Subject has a documented severe congenital or acquired immunodeficiency;
• Subject has had or has planned to receive any organ transplantation;
• Subject undergoes surgery with the indication of being a living liver donor;
• Subject is currently participating or has participated in another clinical investigation within the past 30 days that may affect the endpoints of the study, such as trials related to the surgical procedure, and on anti-coagulation;

Sponsors & Collaborators

• GATT Technologies BV: lead
• Syneos Health: collaborator

Study Sites (10)

University of Southern California

Los Angeles, California, 90033, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Rutgers University

Newark, New Jersey, 07103, United States

Location

Weill-Cornell

New York, New York, 10065, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Intermountain Healthcare

Murray, Utah, 84111, United States

Location

Heidelberg University Hospital

Heidelberg, Germany

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (2)

• Boerman MA, Roozen E, Sanchez-Fernandez MJ, Keereweer AR, Felix Lanao RP, Bender JCME, Hoogenboom R, Leeuwenburgh SC, Jansen JA, Van Goor H, Van Hest JCM. Next Generation Hemostatic Materials Based on NHS-Ester Functionalized Poly(2-oxazoline)s. Biomacromolecules. 2017 Aug 14;18(8):2529-2538. doi: 10.1021/acs.biomac.7b00683. Epub 2017 Jul 25.

  PMID: 28699748 BACKGROUND

• Roozen EA, Warle MC, Lomme RMLM, Felix Lanao RP, van Goor H. New polyoxazoline loaded patches for hemostasis in experimental liver resection. J Biomed Mater Res B Appl Biomater. 2022 Mar;110(3):597-605. doi: 10.1002/jbm.b.34938. Epub 2021 Sep 18.

  PMID: 34536065 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical; Liver Diseases

Interventions

TachoSil

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Digestive System Diseases

Limitations and Caveats

There was a difference in initial evaluation time between ETHIZIA and TachoSil, which followed the products' specific application procedures. TachoSil was chosen as comparator because it is considered current standard-of-care. To optimize its performance, the 3-minute application time for TachoSil adhered to its IFU, rather than being aligned to ETHIZIA's 30-second application time. The 3-minute mark for primary efficacy corresponds with various prior studies on THA in liver surgery.

Results Point of Contact

• Title: Stuart Head MD PhD
• Organization: GATT Technologies

shead2@its.jnj.com

+31645306042

Study Officials

• James Guarrera

  Rutgers New Jersey Medical School, Newark, NJ, USA

  PRINCIPAL INVESTIGATOR

• Hans de Wilt

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to randomized treatment and treatment used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization 2:1

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 23, 2022
• Study Start: August 4, 2022
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: March 4, 2026
• Results First Posted: March 4, 2026

Record last verified: 2026-03

Locations

DE (1); NL (3); US (6)