Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Hospital General Universitario Gregorio Marañon60 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatic Insufficiency Blood Coagulation Disorders

Interventions

Indocyanine green clearanceDRUG

To evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance

ThromboelastometryOTHER

To evaluate blood coagulation impairment by obtaining blood sample from a peripheral vein and measure anticoagulant proteins levels plus obtaining thromboelastometry

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Gregorio Marañon Hospital

Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 1 week

Secondary Outcomes

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

Time frame: 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

Time frame: 2 years

Data from ClinicalTrials.gov

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