Viscoelastic Tests-Guided Therapy In Liver Transplantation

Hospital Israelita Albert Einstein237 enrolled

Overview

BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation. METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

237

Conditions

Liver Transplant; Complications Bleeding Hemostatic Disorder

Interventions

Usual CareOTHER

Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components

Thromboelastometry-Guided Therapy with Synthetic Factor ConcentratesOTHER

Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Deceased Donor Liver Transplantation * Chronic Liver Disease Exclusion Criteria: * Acute Liver Failure * Combined Transplantation * Re-Transplantation is Less Than 30 Days After the First Transplant

Outcomes

Primary Outcomes

Need of Any Blood Products Transfusion

Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.

Time frame: 48 Hours

Secondary Outcomes

Use of Synthetic Factor Concentrates or Antifibrinolytic

Any use of synthetic factor concentrates or antifibrinolytic

Time frame: 48 Hours

Clinical Complications Related to the Procedure

Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event

Time frame: Third days or until hospital discharge, whichever occurs first

Duration of Mechanical Ventilation

Duration of mechanical ventilation in the post-operative period

Time frame: Third days or until hospital discharge, whichever occurs first

ICU Length of Stay

Duration of stay in the intensive care unit

Time frame: Third days or until ICU discharge, whichever occurs first

Hospital Length of Stay

Duration of stay in the hospital

Time frame: Third days or until hospital discharge, whichever occurs first

In-Hospital Mortality

Any death during hospitalization

Time frame: Third days or until hospital discharge, whichever occurs first

Data from ClinicalTrials.gov

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