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

GATT Technologies BV10 sites in 3 countries132 target enrollmentAugust 4, 2022

ConditionsIntraoperative Bleeding Hemorrhage, Surgical Liver Diseases

InterventionsTachoSil GATT-Patch (currently named ETHIZIA)

DrugsTachoSil

Overview

Phase: Not Applicable
Intervention: TachoSil
Conditions: Intraoperative Bleeding
Sponsor: GATT Technologies BV
Enrollment: 132
Locations: 10
Primary Endpoint: Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 4, 2022

End Date

May 10, 2024

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GATT Technologies BV

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

TachoSil

Hemostatic patch

Intervention: TachoSil

GATT-Patch (currently named ETHIZIA)

Hemostatic patch

Intervention: GATT-Patch (currently named ETHIZIA)

TachoSil

Hemostatic patch

Intervention: TachoSil

Outcomes

Primary Outcomes

Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point

Time Frame: During surgical procedure, assessed up to 10 minutes after device application

Surface Bleeding Severity Scale 0

Secondary Outcomes

Mean Time to Hemostasis (Seconds)(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(During surgical procedure, up to the time that hemostasis is achieved)
Rate of Subjects With Treatment Failure(During surgical procedure)
Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure(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(During surgical procedure up to 10 minutes after device application)