Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Completed

• Conditions: Hepatic Insufficiency; Blood Coagulation Disorders
• Interventions: Drug: Indocyanine green clearance; Other: Thromboelastometry

• Registration Number: NCT02813538
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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.

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 Timeline

• Study Start: 2016-02-05
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Primary Completion: 2018-10
• Study Completion: 2019-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IGC and thromboelastometry	Indocyanine green clearance	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
IGC and thromboelastometry	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Gregorio Marañon Hospital; 🇪🇸 Madrid, Spain