GATT-Patch Versus TachoSil in Liver Surgery

NACompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

August 4, 2022

Primary Completion Date

May 10, 2024

Study Completion Date

May 10, 2024

Conditions
Intraoperative BleedingHemorrhage, SurgicalLiver Diseases
Interventions
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."

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."

Trial Locations (10)

10065

Weill-Cornell, New York

28204

Atrium Health, Charlotte

63110

Washington University, St Louis

84111

Intermountain Healthcare, Murray

90033

University of Southern California, Los Angeles

07103

Rutgers University, Newark

Unknown

Heidelberg University Hospital, Heidelberg

University Medical Center Groningen, Groningen

Radboud University Medical Center, Nijmegen

Erasmus MC, Rotterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

GATT Technologies BV

INDUSTRY