Clinical trial NCT03166683: Standard of Care Versus Hemopatch® During Liver Resection
Official title: Standard of Care Versus a New Collagen and Polyethylene Glycol Haemostatic/Sealant Patch (Hemopatch) During Liver Resection. A Multicentre, Non-inferiority Prospective Randomized Study (IBERLIVER-study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Hemorrhage Liver
Bile Leak
Surgery
Tumor Liver
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized (1:1) study of 2 treatment groups (hemopatch versus standard of care) in liver resection surgery. Non-inferiority study
Primary purpose: OTHER

Brief summary: This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.

Detailed description: Liver resection is the only potentially curative treatment in malignant or benign hepatobiliary lesions. Biliary leakage is a postoperative complication (5-10%) which may have considerable consequences. Surgical techniques and devices to facilitate the control of bile leakage have been developed in the last decades and have minimized operative risks of liver resection. Nevertheless, hepatic parenchymal transection can be associated with bile leakage due to the division of small ducts. In order to achieve control over parenchyma from the section surface and to prevent intraperitoneal complications attributed to bile leakage/bleeding various locally applicable agents are in use. This control of bile leakage include fibrin sealant and synthetic glues. Evidence from randomized controlled trials regarding the use of fibrin sealants on their own or combined with a collagenfleece has shown Little efficacy.

A new collagen and polyethylene glycol hemostatic/sealant patch (Hemopatch) \[Baxter, Vienna, Austria\] is indicated for local hemostasis of capillary bleeding and bleeding of parenchymal organs. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus providing an additional impetus as a sealant agent.

The investigators aim to demonstrate the sealing capability of hemopatch and to prove its non-inferiority to the standard of care (may include other sealant / hemostatic devices as patches or liquid/gels). There will be 2 groups to compare. The study group where Hemopatch is applied at the end of surgery. And the control group, where standard of care measures will be applied at the end of surgery. The end-point is the assessment of control of bile leakage at 1, 2, 3, and 4 day, during the hospital stay and or at 30 days for both treatment group. The secondary end-points are bleeding complications (re-bleeding, hematoma formation), volume of fluid drained on day 1 to day 4 after surgery, hemoglobin variation from pre-operative until discharge and post-operatory complications until 30th day pos-op.

Eligibility criteria: Inclusion Criteria:

* Age: ≥18 years.
* Patients with an indication for open liver resection (segmental or non-segmental).
* Target bleeding site of generalized bleeding that persists on the cut surface of the liver in which hemostasis cannot be achieved by conventional methods.
* Willing and able to complete the clinical trial procedures, as described in the protocol.
* Signed written informed consent to participate in this clinical trial.

Exclusion Criteria:

* Presence of coagulation disorder, Klatskin tumour. Cirrhosis, re-hepatectomies and biliary resections
* Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints.
* Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamic acid, activated factor VII, fibrinogen and aprotinin.
* Known allergy or hypersensitivity to a component of the investigational treatments Hemopatch® ,to riboflavin or to proteins of bovine origin.
* Pregnancy or breast-feeding.
* Inability to understand the nature and the extent of the trial and the procedures required.

Criteria to be checked during surgery (intraoperative exclusion criteria):

* Infected wound area.
* Persistent major bleeding after primary hemostasis.

Primary outcomes:
measure: Control of bile leakage
timeFrame: From day 1 to day 4
Secondary outcomes:
measure: Bleeding
timeFrame: From the surgery day until day 30
measure: Analysis of hemoglobin
timeFrame: From the surgery day until day 30
measure: Bleeding complications
timeFrame: From the surgery day until day 30
measure: Transfusion requirements
timeFrame: From the surgery day until day 30
Other outcomes:
measure: Bile leakage severity
timeFrame: From the surgery day until day 30
measure: Morbidity
timeFrame: From the surgery day until day 30
measure: Mortality
timeFrame: From the surgery day until day 30
Locations:
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Miguel Angel Gómez Bravo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumgartner B, Draxler W, Lewis KM. Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy. J Invest Surg. 2016 Dec;29(6):343-351. doi: 10.3109/08941939.2016.1154627. Epub 2016 Mar 22.
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