Clinical trial NCT05385952: GATT-Patch Versus TachoSil in Liver Surgery
Official title: A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Bleeding
Hemorrhage, Surgical
Liver Diseases
Keywords: Hemostatic patch
GATT-Patch
TachoSil
Liver surgery
Hemostasis
Lead sponsor: GATT Technologies BV
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2022-05-23
Enrollment: 131
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 2:1
Primary purpose: TREATMENT

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.


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;
* 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.

Primary outcomes:
measure: Rate of hemostasis at 3 minutes without rebleeding at the 10-minute time point
timeFrame: During surgical procedure
Secondary outcomes:
measure: Mean time to hemostasis (seconds)
timeFrame: During surgical procedure
measure: Kaplan-Meier estimated distribution of time to hemostasis
timeFrame: During surgical procedure
measure: Rate of subjects with treatment failure
timeFrame: During surgical procedure
measure: Rate of subjects with rebleeding after 10 minutes but before subject closure
timeFrame: During surgical procedure
measure: Rate of subjects with hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 seconds
timeFrame: During surgical procedure
Other outcomes:
measure: Procedure duration
timeFrame: During surgical procedure
measure: Estimated blood loss
timeFrame: During surgical procedure
measure: Number and type of blood transfusions
timeFrame: During surgical procedure
measure: Number and type of blood transfusions
timeFrame: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
measure: Mean duration of ICU stay
timeFrame: From surgery to discharge from the ICU, estimated up to 30 days
measure: Mean total hospitalization time
timeFrame: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
measure: Aspect of postoperative drainage
timeFrame: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
measure: Rate of subjects requiring reoperation
timeFrame: During postoperative 3-months follow-up
measure: Rate of subjects with liver resection surface complications on ultrasound
timeFrame: At 6 weeks follow-up visit
measure: Amount of hemostatic material needed versus bleeding surface
timeFrame: During surgical procedure
measure: System Usability Score (SUS) user satisfaction questionnaire
timeFrame: At completion of the surgical procedure, at day 0
measure: GATT-Patch device-specific user satisfaction questionnaire
timeFrame: At completion of the surgical procedure, at day 0
measure: Local recurrence of liver cancer at the resection
timeFrame: 5 years
measure: Cancer-free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
city: New York
country: United States
facility: Weill-Cornell
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Rutgers New Jersey Medical School, Newark, NJ, USA
name: James Guarrera
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Hans de Wilt
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.