At a glance
ClinicalIndex Comparison Record- ✓Scheduled for elective open liver surgery
- ✓Age ≥22 years at enrollment
- ✓Intraoperatively: target bleeding site at liver resection plane where conventional hemostasis (suture, ligature, cautery) is ineffective or impractical, requiring hemostatic agent
- ✓Target bleeding site severity SBSS score 1, 2, or 3 (minimal, mild, or moderate)
- ✕Target bleeding site from large arterial or venous defect requiring vascular reconstruction with vessel patency maintenance
- ✕Planned surgery on organs other than liver, biliary, or vascular system
- ✕Planned staged liver surgery (e.g., ALPPS)
- ✕Multiple antithrombotic therapies at therapeutic dosage up to surgery (aspirin monotherapy allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery
In Brief
A clinical study evaluating GATT-Patch (currently named ETHIZIA) and TachoSil for Intraoperative Bleeding and 2 related conditions. Completed, enrolled 132 participants across 10 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.