Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-bound Fibrin Sealant During Liver Resection (ESSCALIVER)
Brief Summary: This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres. The primary objective of this study is to show that the collagen based haemostatic device Sangustop® is not inferior to a carrier-bound fibrin sealant (Tachosil®) in achieving haemostasis after hepatic resection.


Options:
A: 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.
B: 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)
C: Inclusion Criteria:

* Patients scheduled for elective hepatic resection
* Stapler hepatectomy and clamp-crushing feasible based on preoperative imaging
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Participation in concurrent intervention trials
* Expected lack of compliance
* Impaired mental state or language problems
D: Inclusion:

* Age: \> 18 years
* Gender: male / female
* Patients with an indication for liver resection (segmental or non-segmental)
* 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:

* Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor
* 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 tranexamix acid, activated factor VII, and aprotinine
* Known allergy or hypersensitivity to a component of the investigational treatments Sangustop® or TachoSil®, 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
* Missing signed written informed consent to participate in the study

Exclusion criteria to be checked during surgery (liver resection):

* Resection area estimated by operating surgeon \< 16cm2
* Infected wound area
* Persistant major bleeding after primary haemostasis
* No bleeding after resection

Answer: D