Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Sponsor

Hospital General Universitario Gregorio Marañon (Other)

Overall Status

Completed

CT.gov ID

NCT02813538

Collaborator

(none)

Enrollment

Location

37.8

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency Blood Coagulation Disorders	Drug: Indocyanine green clearance Other: Thromboelastometry

Detailed Description

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Hypercoagulability and Liver Function After Major Liver Resection

Actual Study Start Date :

Feb 5, 2016

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
IGC and thromboelastometry 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 To evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance Other Names: Verdye Other: Thromboelastometry To evaluate blood coagulation impairment by obtaining blood sample from a peripheral vein and measure anticoagulant proteins levels plus obtaining thromboelastometry

Arm

Intervention/Treatment

IGC and thromboelastometry

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

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

Other Names:

Verdye

Other: Thromboelastometry

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

Outcome Measures

Primary Outcome Measures

Establish a relationship between ICG and MCF [1 week]
We aim to find a potential association between ICG and MCF measured by thromboelastometry in the first week after surgery
Establish a relationship between pro and anticoagulant proteins levels and endothelial markers [1 week]
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

Secondary Outcome Measures

Study blood coagulation disorders after major liver surgery resection [2 years]
We aim to characterize blood coagulation disorders during the first week after major liver surgery in our sample of patients
Study liver function after major liver surgery [2 years]
We aim to study the predictive value of indocyanine green clearance for liver impairment after major liver surgery in our sample of patients