GATT-Patch Versus TachoSil in Liver Surgery

Not Applicable

Completed

Conditions: Hemorrhage, Surgical
Liver Diseases
Intraoperative Bleeding

Interventions: Drug: TachoSil
Device: GATT-Patch

Registration Number: NCT05385952

Lead Sponsor: GATT Technologies BV

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 131

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TachoSil	TachoSil	Hemostatic patch
GATT-Patch	GATT-Patch	Hemostatic patch

Primary Outcome Measures

Name	Time	Method
Rate of hemostasis at 3 minutes without rebleeding at the 10-minute time point	During surgical procedure	SBSS 0

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier estimated distribution of time to hemostasis	During surgical procedure	SBSS 0
Rate of subjects with rebleeding after 10 minutes but before subject closure	During surgical procedure	SBSS 1-5 after initially SBSS 0
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	SBSS 0-5
Mean time to hemostasis (seconds)	During surgical procedure	SBSS 0
Rate of subjects with treatment failure	During surgical procedure	SBSS 1-5 at the 10 minute timepoint

Trial Locations

Locations (10): University of Southern California
🇺🇸
Los Angeles, California, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
Atrium Health
🇺🇸
Charlotte, North Carolina, United States
Intermountain Healthcare
🇺🇸
Murray, Utah, United States
Weill-Cornell
🇺🇸
New York, New York, United States
Rutgers University
🇺🇸
Newark, New Jersey, United States
Heidelberg University Hospital
🇩🇪
Heidelberg, Germany
Radboud University Medical Center
🇳🇱
Nijmegen, Netherlands
Erasmus MC
🇳🇱
Rotterdam, Netherlands
University Medical Center Groningen
🇳🇱
Groningen, Netherlands