Intraoperative BleedingNCT05385952

GATT-Patch Versus TachoSil in Liver Surgery

A study testing GATT-Patch (currently named ETHIZIA) and TachoSil in people with Intraoperative Bleeding and Hemorrhage, Surgical, run by GATT Technologies BV at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
What is being tested?: GATT-Patch (currently named ETHIZIA) and TachoSil
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 10 sitesin 3 countries
Study dates: 4 Aug 2022to 10 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

Show all 17Show fewer

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.

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

United States6 sites

Atrium Health
Charlotte, North Carolina, 28204
University of Southern California
Los Angeles, California, 90033
Intermountain Healthcare
Murray, Utah, 84111
Weill-Cornell
New York, New York, 10065
Rutgers University
Newark, New Jersey, 07103
Washington University
St Louis, Missouri, 63110

Other trials in United States

Netherlands3 sites

University Medical Center Groningen
Groningen
Radboud University Medical Center
Nijmegen
Erasmus MC
Rotterdam

Other trials in Netherlands

Germany1 site

Heidelberg University Hospital
Heidelberg

Other trials in Germany

About this study

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

Conditions: Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
Being tested: GATT-Patch (currently named ETHIZIA), TachoSil
Keywords: Hemostatic patch, GATT-Patch, TachoSil, Liver surgery, Hemostasis
Medical subject headings: Blood Loss, Surgical, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GATT-Patch (currently named ETHIZIA)Device
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.
TachoSilDrug
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.

Study groups in NCT05385952
Study group	Role	What they receive
GATT-Patch (currently named ETHIZIA)	Experimental	Hemostatic patch Receives: Device: GATT-Patch (currently named ETHIZIA)
TachoSil	Active comparator	Hemostatic patch Receives: Drug: TachoSil

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point
Surface Bleeding Severity Scale 0
Measured: During surgical procedure, assessed up to 10 minutes after device application

Secondary outcomes (5)

Mean Time to Hemostasis (Seconds)
Surface Bleeding Severity Scale 0
Measured: 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
Surface Bleeding Severity Scale 0
Measured: During surgical procedure, up to the time that hemostasis is achieved
Rate of Subjects With Treatment Failure
SBSS 1-5 at the 10 minute timepoint
Measured: During surgical procedure
Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure
Surface Bleeding Severity Scale 1-5 after initially Surface Bleeding Severity Scale 0
Measured: 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
Surface Bleeding Severity Scale 0-5
Measured: During surgical procedure up to 10 minutes after device application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202210 May 2024

First posted23 May 2022
Study start4 Aug 2022
Primary completion10 May 2024
Study completion10 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Intraoperative BleedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomization 2:1
Masking: Single blind
Who is masked: Participant
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05385952
Sponsor's protocol ID: DHF-01-SFT-194
Status last verified: Mar 2026
First submitted: 29 Apr 2022
Last updated: 4 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 28699748
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.
PubMed 34536065
Guarrera JV, Kaur N, Verhoef C, Zendejas I, Botha J, Fouraschen SMG, Paterno F, Pianka F, Porte RJ, Samstein B, Sher L, Wellen JR, Bender JCME, Fossan I, Head SJ, de Wilt JHW; ETHIZIA Open Liver Study Collaborator Group. Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled multicenter trial. HPB (Oxford). 2026 Aug;28(8):1064-1075. doi: 10.1016/j.hpb.2026.04.466. Epub 2026 May 7.
PubMed 42177141

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intraoperative Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery
ClinicalTrials.gov ID: NCT05385952
Acronym / sponsor ID: DHF-01-SFT-194
Conditions: Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
Keywords: Hemostatic patch, GATT-Patch, TachoSil, Liver surgery, Hemostasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: GATT Technologies BVIndustry (pharma, biotech, devices)
Collaborators: Syneos Health
Study start: 4 Aug 2022 (actual)
Primary completion: 10 May 2024 (actual)
Study completion: 10 May 2024 (actual)
First posted: 23 May 2022 (actual)
Results: Posted 4 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomization 2:1

Arm	Type	Receives
GATT-Patch (currently named ETHIZIA)	Experimental	Device: GATT-Patch (currently named ETHIZIA)Hemostatic patch
TachoSil	Active comparator	Drug: TachoSilHemostatic patch

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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:

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	GATT-Patch (currently named ETHIZIA)
TachoSilTachoSil 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.	Drug	TachoSil

Primary outcome

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

5 secondary outcomes

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

Results and safety

Results posted to the registry on 4 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GATT-Patch (Currently Named ETHIZIA)	88	79
TachoSil	44	41

Primary outcome: 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. Count of participants. Unit: Participants

Measure	GATT-Patch (Currently Named ETHIZIA) n = 87	TachoSil n = 43
Value	81	33

Population analysed: Per protocol population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GATT-Patch (Currently Named ETHIZIA)	37 of 87 (42.5%)	66 of 87 (75.9%)	5 of 87
TachoSil	10 of 43 (23.3%)	31 of 43 (72.1%)	1 of 43

Limitations and caveats (from the sponsor): There was a difference in initial evaluation time between ETHIZIA and TachoSil, which followed the products' specific application procedures. TachoSil was chosen as comparator because it is considered current standard-of-care. To optimize its performance, the 3-minute application time for TachoSil adhered to its IFU, rather than being aligned to ETHIZIA's 30-second application time. The 3-minute mark for primary efficacy corresponds with various prior studies on THA in liver surgery.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28699748Boerman 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.
Background: PubMed 34536065Roozen 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.
Derived from this study: PubMed 42177141Guarrera JV, Kaur N, Verhoef C, Zendejas I, Botha J, Fouraschen SMG, Paterno F, Pianka F, Porte RJ, Samstein B, Sher L, Wellen JR, Bender JCME, Fossan I, Head SJ, de Wilt JHW; ETHIZIA Open Liver Study Collaborator Group. Safety and effectiveness of ETHIZIA versus TachoSil for hemostasis during open liver surgery: a randomized controlled multicenter trial. HPB (Oxford). 2026 Aug;28(8):1064-1075. doi: 10.1016/j.hpb.2026.04.466. Epub 2026 May 7.
Individual participant dataSharing planned: Undecided

Related trials for Intraoperative Bleeding

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James Guarrera principal investigator

Rutgers New Jersey Medical School, Newark, NJ, USA

Hans de Wilt principal investigator

Radboud University Medical Center

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GATT-Patch (currently named ETHIZIA) and TachoSil in people with Intraoperative Bleeding and Hemorrhage, Surgical, run by GATT Technologies BV at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05385952, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.