Please select the eligibility criteria that correspond to the clinical trial below.
Title: IVC CLAMP: Infrahepatic Inferior Vena Cava Clamping During Hepatectomy - A Randomized Controlled Trial
Brief Summary: Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.

In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.


Options:
A: 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
B: Inclusion Criteria:

1. patients who were assessed by preoperative medical imagings to have a high risk of backflow bleeding from the major hepatic veins and the IVC, based on the size and location of the tumor. The tumors were ≥5 cm in diameter and they involved the liver segments 7, 8 and/or the cranial portion of segment 4. These tumors were in close proximity or were compressing, but had not actually invaded, the major hepatic veins or IVC
2. Pugh-Child Grade A
3. Indocyanine green retention rate at 15 minutes (ICGR15) \< 10%;
4. acceptable clotting profile (platelet count ≥ 50 ×109/L and prothrombin activity ≥ 60%)
5. no previous liver resection.

Exclusion Criteria:

1. extrahepatic metastases in patients with malignancy;
2. patients who refused to take part in this study.
C: 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
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 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

Answer: A