Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Hypercoagulability and Liver Function After Major Liver Resection

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Insufficiency; Blood Coagulation Disorders
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Gregorio Marañon hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Gregorio Marañon
• Investigators: Study Director: Luis Olmedilla, PhD, Gregorio Marañon hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Liver surgery; Liver function tests; Thrombelastography; Antithrombin proteins
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Liver Diseases; Hemorrhagic Disorders; Liver Failure; Hepatic Insufficiency; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: HGUGregorioMaranonCRH2AT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publishing results
• IPD Sharing Time Frame: From december 2018
• IPD Sharing Access Criteria: For other researchers and editors
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)