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Major Liver Resection: Early Clotting Disorders and Functional Impairment.

H

Hospital General Universitario Gregorio Marañon

Status

Completed

Conditions

Hepatic Insufficiency
Blood Coagulation Disorders

Treatments

Other: Thromboelastometry
Drug: Indocyanine green clearance

Study type

Observational

Funder types

Other

Identifiers

NCT02813538
HGUGregorioMaranonCRH2AT

Details and patient eligibility

About

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.

Full 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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

IGC and thromboelastometry
Description:
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
Treatment:
Drug: Indocyanine green clearance
Other: Thromboelastometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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