GATT-Patch Versus TachoSil in Liver Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases

Intervention / Treatment
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* Device: GATT-Patch
* Drug: TachoSil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization 2:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GATT-Patch<br>Hemostatic patch | Device: GATT-Patch<br>* GATT-Patch 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.<br>|
| Active Comparator: TachoSil<br>Hemostatic patch | Drug: TachoSil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hemostasis at 3 minutes without rebleeding at the 10-minute time point | SBSS 0 | During surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to hemostasis (seconds) | SBSS 0 | During surgical procedure | 
| Kaplan-Meier estimated distribution of time to hemostasis | SBSS 0 | During surgical procedure | 
| 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 | SBSS 1-5 after initially SBSS 0 | During surgical procedure | 
| Rate of subjects with hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 seconds | SBSS 0-5 | During surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostatic patch, GATT-Patch, TachoSil, Liver surgery, Hemostasis