GATT-Patch Versus TachoSil in Liver Surgery

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Intraoperative Bleeding; Hemorrhage, Surgical
• Intervention / Treatment: Drug: TachoSil; Device: GATT-Patch (currently named ETHIZIA)

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • Heidelberg University Hospital
• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Nijmegen, Netherlands
    • Radboud University Medical Center
  • Rotterdam, Netherlands
    • Erasmus MC
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers University
  • New York
    • New York, New York, United States, 10065
      • Weill-Cornell
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health
  • Utah
    • Murray, Utah, United States, 84111
      • Intermountain Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

A subject must meet all of the following intra-operative inclusion criteria to be enrolled into 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).

Exclusion Criteria:

• 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;
• Subject is not appropriate for inclusion in the clinical investigation, per the medical opinion of the Investigator; and
• Subject has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TachoSil; Hemostatic patch	Drug: TachoSil; 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.
Experimental: GATT-Patch (currently named ETHIZIA); Hemostatic patch	Device: GATT-Patch (currently named ETHIZIA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Time to Hemostasis (Seconds)	Surface Bleeding Severity Scale 0	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	Surface Bleeding Severity Scale 0	During surgical procedure, up to the time that hemostasis is achieved
Rate of Subjects With Treatment Failure	SBSS 1-5 at the 10 minute timepoint	During surgical procedure
Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure	Surface Bleeding Severity Scale 1-5 after initially Surface Bleeding Severity Scale 0	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	Surface Bleeding Severity Scale 0-5	During surgical procedure up to 10 minutes after device application

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Duration	Time in minutes	During surgical procedure
Estimated Blood Loss	mL	During surgical procedure
Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma	Platelets, Erythrocytes, Plasma	During surgical procedure
Number and Type of Blood Transfusions	Platelets, Erythrocytes, Plasma	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Mean Duration of ICU Stay	Time in hours	From surgery to discharge from the ICU, estimated up to 30 days
Mean Total Hospitalization Time	Time in days	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Aspect of Postoperative Drainage	Serous, sanguineous, serosanguineous, other Sanguineous Serosanguinous Serous, Sanguineous, Serosanguineous, Purulent, Other	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Rate of Subjects Requiring Reoperation	Occurrence yes/no	During postoperative 3-months follow-up
Rate of Subjects With Liver Resection Surface Complications on Ultrasound	Patch encapsulation, patch rolling up on the surface, pseudoaneurysm, fluid collection	At 6 weeks follow-up visit
Amount of Hemostatic Material Needed Versus Bleeding Surface	cm2 patch per cm2 bleeding	During surgical procedure
System Usability Score (SUS) User Satisfaction Questionnaire	Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome for uneven questions and (strongly) disagreeing meaning a better outcome for even questions	At completion of the surgical procedure, at day 0
GATT-Patch Device-specific User Satisfaction Questionnaire	Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome	At completion of the surgical procedure, at day 0
Local Recurrence of Liver Cancer at the Resection	Occurrence yes/no	5 years
Cancer-free Survival	Occurrence yes/no	5 years
Overall Survival	Occurrence yes/no	5 years

Collaborators and Investigators

• Sponsor: GATT Technologies BV
• Collaborators: Syneos Health
• Investigators: Principal Investigator: James Guarrera, Rutgers New Jersey Medical School, Newark, NJ, USA; Principal Investigator: Hans de Wilt, Radboud University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• GATT Technologies B.V. website

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hemostasis; Liver surgery; Hemostatic patch; GATT-Patch; TachoSil
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Hemorrhage; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Liver Diseases; Blood Loss, Surgical; TachoSil
• Other Study ID Numbers: DHF-01-SFT-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes