Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Brief Summary: The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) 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:

* Aged 18 years
* Scheduled for elective hepatic resection due to any reason
* American Society of Anesthesiologists (ASA) score I to III
* Written informed consent

Exclusion Criteria:

* Medical conditions exposing patient at increased risk for not tolerating liver resection:
* Cirrhosis (Child-Pugh B and C)
* (Hereditary) coagulopathy
* Medical conditions exposing patient at increased risk for not tolerating this trial's study interventions:
* Severe heart disease (e.g. severe CAD requiring intervention, NYHA IV)
* Pulmonary hypertension
* Renal insufficiency (serum creatinin \>2mg/dl or \>177µmol/l; conversion factor 88.4 or requiring dialysis)
* Severe hypernatremia (serum sodium \>155mmol/l)
* Severe hyperchloremia
* For female subjects: pregnancy and lactation
* Impaired mental state or language problems
* Participation in other clinical trials or observation period of competing trials interfering with the endpoints of this trial
* Former participation in the clinical trial
* Expected lack of compliance
C: Inclusion Criteria:

1. Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
2. Is undergoing one of the 4 surgical procedures described
3. Is at least 18 years old at time of consent
4. If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
5. If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse
6. Has not received blood transfusion between screening and study treatment
7. Has mild to moderate surgical bleeding
8. Does not have intra-operative complications
9. Has not used a topical hemostat containing thrombin prior to study treatment
10. Has an approximate bleeding site surface area of less than or equal to 100 cm\^2

Exclusion Criteria:

1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors
2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
3. Has known allergy to gelatin sponge
4. Is unwilling to receive blood products
5. Has liver enzymes appropriate for the study, considering their disease
6. Has appropriate level of platelets per liter (PLT/L) during screening
7. Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
D: Inclusion Criteria:

* Adults (\>18 years).
* Pre-operative hemoglobin concentration \>= 11 mg/dl (males); \>= 10 mg/dl (females) within 14 days of registration.
* Patients scheduled for resection of 3 or more liver segments for any indication, with or without other planned procedures or patients scheduled for pancreaticoduodenectomy

Exclusion Criteria:

* A history of active coronary artery disease. Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal left ventricular (LV) function within 30 days of operation.
* A history of cerebrovascular disease.
* A history of congestive heart failure.
* A history of uncontrolled hypertension.
* A history of restrictive or obstructive pulmonary disease.
* A history of renal dysfunction (creatinine \[Cr\] \> 1.8).
* Abnormal coagulation parameters (International Normalized Ratio \[INR\] \> 1.5 not on Coumadin, or platelet count \< 100,000).
* Presence of active infection.
* Evidence of hepatic metabolic disorder (bilirubin \> 2 mg/dl, ALT \> 75 U/L in the absence of biliary tract obstruction).
* Pre-operative autologous blood donation.

Answer: A