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Completed

NCT Number: NCT02813538

Major Liver Resection: Early Clotting Disorders and Functional Impairment.

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.

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Key information

Conditions

Hepatic Insufficiency Blood Coagulation Disorders Digestive System Diseases Hematologic Diseases Hemic and Lymphatic Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gregorio Marañon Hospital

Madrid, 28007, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green clearance

Drug

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

Other names: Verdye

Thromboelastometry

Other

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

Primary outcomes

  1. Establish a relationship between ICG and MCF

    Time frame: 1 week

    We aim to find a potential association between ICG and MCF measured by thromboelastometry in the first week after surgery

  2. Establish a relationship between pro and anticoagulant proteins levels and endothelial markers

    Time frame: 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 outcomes

  1. Study blood coagulation disorders after major liver surgery resection

    Time frame: 2 years

    We aim to characterize blood coagulation disorders during the first week after major liver surgery in our sample of patients

  2. Study liver function after major liver surgery

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Registry information

Official study title

Hypercoagulability and Liver Function After Major Liver Resection

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 27, 2016
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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