Skip to main content
OpenTrials
Completed

NCT Number: NCT03756948

Viscoelastic Tests-Guided Therapy In Liver Transplantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Transplant; Complications Bleeding Blood Coagulation Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorder Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Usual Care

Other

Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Other

Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates

Primary outcomes

  1. Need of Any Blood Products Transfusion

    Time frame: 48 Hours

    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.

Secondary outcomes

  1. Use of Synthetic Factor Concentrates or Antifibrinolytic

    Time frame: 48 Hours

    Any use of synthetic factor concentrates or antifibrinolytic

  2. Clinical Complications Related to the Procedure

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

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

  3. Duration of Mechanical Ventilation

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

    Duration of mechanical ventilation in the post-operative period

  4. ICU Length of Stay

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

    Duration of stay in the intensive care unit

  5. Hospital Length of Stay

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

    Duration of stay in the hospital

  6. In-Hospital Mortality

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

    Any death during hospitalization

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study

Acronym: VETLT

Important dates

Study start
2007
Primary completion
2015
Study completion
2018
First posted
Nov 28, 2018
Registry last updated
Nov 28, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.