Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Study Overview
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Brief Summary
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The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver resection and search for a potential relationship between them.

Detailed Description
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We are prospectively recording data from patients undergoing major liver resection. We obtain a full procoagulant and anticoagulant profile preoperatively and, at first, second and sixth day after surgery. We also measure indocyanine green (ICG) clearance preoperatively and in the first two postoperative days. We are also recording clinical data, focusing on medical and surgical complications. We aim to establish the potential value of ICG clearance and or coagulation profile to predict clinical complications

Official Title
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Hypercoagulability and Liver Function After Major Liver Resection

Conditions
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Hepatic Insufficiency, Blood Coagulation Disorders

Intervention / Treatment
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* Drug: Indocyanine green clearance
* Other: Thromboelastometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments Exclusion Criteria: Indocyanin green allergy Thyrotoxicosis Thrombophilia Lupus anticoagulant Coagulation factor deficiency Venous thromboembolism in the last 3 years Pulmonary thromboembolism in the last 3 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IGC and thromboelastometry<br>Patients that have hyper, normo o hypcoagulability measured by tromboelastometry and anticoagulant proteins levels early after major liver resection and clinical evolution and patients with liver funcion impairment or without it, measured by indocyanine green clearance early after surgery and clinical evolution | Drug: Indocyanine green clearance<br>* To evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance<br>* Other names: Verdye;Other: Thromboelastometry<br>* To evaluate blood coagulation impairment by obtaining blood sample from a peripheral vein and measure anticoagulant proteins levels plus obtaining thromboelastometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a relationship between ICG and MCF | We aim to find a potential association between ICG and MCF measured by thromboelastometry in the first week after surgery | 1 week | 
| Establish a relationship between pro and anticoagulant proteins levels and endothelial markers | We aim to find a potential association between procoagulant factor levels, protein C,S and ATIII with thrombomodulin, heparan sulfate and syndecan-1 in the first week after surgery | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study blood coagulation disorders after major liver surgery resection | We aim to characterize blood coagulation disorders during the first week after major liver surgery in our sample of patients | 2 years | 
| Study liver function after major liver surgery | We aim to study the predictive value of indocyanine green clearance for liver impairment after major liver surgery in our sample of patients | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombelastography, Antithrombin proteins, Liver surgery, Liver function tests