Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
Brief Summary: To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.


Options:
A: Inclusion Criteria:

* Subjects \> 18 years of age, requiring elective or urgent, open hepatic surgery
* Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
* Subjects must be willing to participate in the study, and provide written informed consent

Exclusion Criteria:

* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
* TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the FP to blood flow and pressure during healing and absorption of the product
* TBS with major arterial bleeding requiring suture or mechanical ligation
* Subjects admitted for trauma surgery
* Subject is a transplant patient for fulminant hepatic failure
* Subject with TBS within an actively infected field
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
* Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products
* Subjects who are known, current alcohol and / or drug abusers
* Subjects who have participated in another investigational drug or device research study within 30 days of surgery
* Female subjects who are pregnant or nursing
B: Inclusion Criteria:

* Resection of at least the equivalent tissue volume of 1 anatomical segment of the liver
* Minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation
* Need for additional supportive hemostatic treatment
* Expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes

Exclusion Criteria:

* Indication for emergency surgery
* Known coagulopathy (as judged relevant by the investigator)
* Known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin)
* Patient unwilling to receive blood products
* Known current alcohol or drug abuse
* Pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential
* Dry surgical field of the targeted application area
* Occurrence of any serious surgical complication
* Disseminated intravascular coagulopathy (DIC), i.e. microvascular bleeding
* Application of topical hemostatic material on the liver resection wound
* Radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment
C: Inclusion Criteria

* Patient undergoing anticipated open or laparoscopic major liver resection (\> 2 hepatic segments), as assessed by the operating surgeon
* Age ≥ 18 years.

Exclusion Criteria

* Previously enrolled in this study
* Platelet count less than 100,000/mm3
* Severe anemia (hemoglobin levels less than 90 g/l)
* Documented arterial or venous thrombosis at screening or in past three months
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
* Hepatectomy associated with planned vascular or biliary reconstruction
* Known disseminated intravascular coagulation
* Severe renal insufficiency (CrCl\<30)
* History of seizure disorder
* Pregnant or lactating
* Hypersensitivity to tranexamic acid or any of the ingredients
* Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction)
* Receipt of chemotherapy within 4 weeks of scheduled operation
* Patients undergoing resection for living donor liver transplant.
D: Inclusion Criteria:

* Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.
* Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
* Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

Exclusion Criteria:

* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
* TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST® to blood flow and pressure during healing and absorption of the product;
* TBS with major arterial bleeding requiring suture or mechanical ligation;
* Subjects admitted for trauma surgery;
* Subject is a transplant patient for fulminant hepatic failure
* Subject with TBS within an actively infected field;
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
* Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
* Subjects who are known, current alcohol and / or drug abusers;
* Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
* Female subjects who are pregnant or nursing.

Answer: D