Major Liver Resection: Early Clotting Disorders and Functional Impairment.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-05

Study Completion Date

2019-04-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Hepatic Insufficiency Blood Coagulation Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Indocyanine green clearance

Intervention Type DRUG

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

Thromboelastometry

Intervention Type OTHER

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

Interventions

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Indocyanine green clearance

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

Intervention Type DRUG

Thromboelastometry

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

Intervention Type OTHER

Other Intervention Names

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Verdye

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No