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Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Hypercoagulability and Liver Function After Major Liver Resection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02813538
Enrollment
60
Registered
2016-06-27
Start date
2016-02-05
Completion date
2019-04-30
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Insufficiency, Blood Coagulation Disorders

Keywords

Thrombelastography, Antithrombin proteins, Liver surgery, Liver function tests

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

Interventions

DRUGIndocyanine green clearance

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

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

Sponsors

Hospital General Universitario Gregorio Marañon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Establish a relationship between ICG and MCF1 weekWe 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 markers1 weekWe 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

MeasureTime frameDescription
Study blood coagulation disorders after major liver surgery resection2 yearsWe 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 surgery2 yearsWe aim to study the predictive value of indocyanine green clearance for liver impairment after major liver surgery in our sample of patients

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026