GATT-Patch Versus TachoSil in Liver Surgery

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385952
• Other study ID #: DHF-01-SFT-194
• Status: Completed
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: May 10, 2024

Study information

• Verified date: June 2024
• Source: GATT Technologies BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: May 10, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Hemorrhage, Surgical
• Intraoperative Bleeding
• Liver Diseases

Intervention

Device:
• GATT-Patch
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.

Drug:
• 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.

Locations

Country	Name	City	State
Germany	Heidelberg University Hospital	Heidelberg
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Erasmus MC	Rotterdam
United States	Atrium Health	Charlotte	North Carolina
United States	University of Southern California	Los Angeles	California
United States	Intermountain Healthcare	Murray	Utah
United States	Weill-Cornell	New York	New York
United States	Rutgers University	Newark	New Jersey
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
GATT Technologies BV	Syneos Health

Countries where clinical trial is conducted

United States,  Germany,  Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure duration	Time in minutes	During surgical procedure
Other	Estimated blood loss	mL	During surgical procedure
Other	Number and type of blood transfusions	Platelets, Erythrocytes, Plasma	During surgical procedure
Other	Number and type of blood transfusions	Platelets, Erythrocytes, Plasma	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Other	Mean duration of ICU stay	Time in hours	From surgery to discharge from the ICU, estimated up to 30 days
Other	Mean total hospitalization time	Time in days	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Other	Aspect of postoperative drainage	Serous, sanguineous, serosanguineous, other Sanguineous Serosanguinous Serous, Sanguineous, Serosanguineous, Purulent, Other	During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 days
Other	Rate of subjects requiring reoperation	Occurrence yes/no	During postoperative 3-months follow-up
Other	Rate of subjects with liver resection surface complications on ultrasound	Fluid collection, biloma, hematoma, patch encapsulation, patch rolling up on the surface	At 6 weeks follow-up visit
Other	Amount of hemostatic material needed versus bleeding surface	cm2 patch per cm2 bleeding	During surgical procedure
Other	System Usability Score (SUS) user satisfaction questionnaire	Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome for uneven questions and (strongly) disagreeing meaning a better outcome for even questions	At completion of the surgical procedure, at day 0
Other	GATT-Patch device-specific user satisfaction questionnaire	Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome	At completion of the surgical procedure, at day 0
Other	Local recurrence of liver cancer at the resection	Occurrence yes/no	5 years
Other	Cancer-free survival	Occurrence yes/no	5 years
Other	Overall survival	Occurrence yes/no	5 years
Primary	Rate of hemostasis at 3 minutes without rebleeding at the 10-minute time point	SBSS 0	During surgical procedure
Secondary	Mean time to hemostasis (seconds)	SBSS 0	During surgical procedure
Secondary	Kaplan-Meier estimated distribution of time to hemostasis	SBSS 0	During surgical procedure
Secondary	Rate of subjects with treatment failure	SBSS 1-5 at the 10 minute timepoint	During surgical procedure
Secondary	Rate of subjects with rebleeding after 10 minutes but before subject closure	SBSS 1-5 after initially SBSS 0	During surgical procedure
Secondary	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

External Links

•   GATT Technologies B.V. website