Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Hepatic Insufficiency Clinical Trial

Official title:

Hypercoagulability and Liver Function After Major Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813538
• Other study ID #: HGUGregorioMaranonCRH2AT
• Status: Completed
• Start date: February 5, 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2020
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Hepatic Insufficiency
• Liver Failure

Intervention

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

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

Locations

Country	Name	City	State
Spain	Gregorio Marañon Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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