Study Results
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Basic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2022-08-04
2024-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GATT-Patch (currently named ETHIZIA)
Hemostatic patch
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.
TachoSil
Hemostatic patch
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
22 Years
ALL
No
Sponsors
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Syneos Health
OTHER
GATT Technologies BV
INDUSTRY
Responsible Party
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Principal Investigators
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James Guarrera
Role: PRINCIPAL_INVESTIGATOR
Rutgers New Jersey Medical School, Newark, NJ, USA
Hans de Wilt
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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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
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
Countries
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References
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Boerman MA, Roozen E, Sanchez-Fernandez MJ, Keereweer AR, Felix Lanao RP, Bender JCME, Hoogenboom R, Leeuwenburgh SC, Jansen JA, Van Goor H, Van Hest JCM. Next Generation Hemostatic Materials Based on NHS-Ester Functionalized Poly(2-oxazoline)s. Biomacromolecules. 2017 Aug 14;18(8):2529-2538. doi: 10.1021/acs.biomac.7b00683. Epub 2017 Jul 25.
Roozen EA, Warle MC, Lomme RMLM, Felix Lanao RP, van Goor H. New polyoxazoline loaded patches for hemostasis in experimental liver resection. J Biomed Mater Res B Appl Biomater. 2022 Mar;110(3):597-605. doi: 10.1002/jbm.b.34938. Epub 2021 Sep 18.
Other Identifiers
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DHF-01-SFT-194
Identifier Type: -
Identifier Source: org_study_id
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