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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
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.
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.
University of Southern California
Los Angeles, California, United States
Washington University
St Louis, Missouri, United States
Rutgers University
Newark, New Jersey, United States
Weill-Cornell
Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point
Surface Bleeding Severity Scale 0
Time frame: During surgical procedure, assessed up to 10 minutes after device application
Mean Time to Hemostasis (Seconds)
Surface Bleeding Severity Scale 0
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During surgical procedure up to 10 minutes after device application
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New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Intermountain Healthcare
Murray, Utah, United States
Heidelberg University Hospital
Heidelberg, Germany
University Medical Center Groningen
Groningen, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands