Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
Conditions
Keywords
Hemostatic patch, GATT-Patch, TachoSil, Liver surgery, Hemostasis
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.
Interventions
DEVICEGATT-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.
DRUGTachoSil
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.
Sponsors
GATT Technologies BV
Syneos Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to randomized treatment and treatment used.
Intervention model description
Randomization 2:1
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point | During surgical procedure, assessed up to 10 minutes after device application | Surface Bleeding Severity Scale 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Surface Bleeding Severity Scale 0 |
| Kaplan-Meier Estimated Distribution of Time to Hemostasis | During surgical procedure, up to the time that hemostasis is achieved | Surface Bleeding Severity Scale 0 |
| Rate of Subjects With Treatment Failure | During surgical procedure | SBSS 1-5 at the 10 minute timepoint |
| Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure | During surgical procedure up to patient closure | Surface Bleeding Severity Scale 1-5 after initially Surface Bleeding Severity Scale 0 |
| 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 | Surface Bleeding Severity Scale 0-5 |
Countries
Germany, Netherlands, United States
Contacts
PRINCIPAL_INVESTIGATORJames Guarrera
Rutgers New Jersey Medical School, Newark, NJ, USA
PRINCIPAL_INVESTIGATORHans de Wilt
Radboud University Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 107 Participants |
| Region of Enrollment Germany | 5 participants |
| Region of Enrollment Netherlands | 50 participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 87 | 1 / 43 |
| other Total, other adverse events | 66 / 87 | 31 / 43 |
| serious Total, serious adverse events | 37 / 87 | 10 / 43 |
Outcome results
None listed