Viscoelastic Tests-Guided Therapy In Liver Transplantation (VETLT)

November 27, 2018 updated by: Hospital Israelita Albert Einstein

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care (Before)
No Thromboelastometry No Synthetic Factor Concentrates Usual Care
Other: Usual Care
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
Experimental: Thromboelastometry-Guided Therapy (After)
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Synthetic Factor Concentrates or Antifibrinolytic
Time Frame: 48 Hours
Any use of synthetic factor concentrates or antifibrinolytic
48 Hours
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
Third days or until hospital discharge, whichever occurs first
Duration of Mechanical Ventilation
Time Frame: Third days or until hospital discharge, whichever occurs first
Duration of mechanical ventilation in the post-operative period
Third days or until hospital discharge, whichever occurs first
ICU Length of Stay
Time Frame: Third days or until ICU discharge, whichever occurs first
Duration of stay in the intensive care unit
Third days or until ICU discharge, whichever occurs first
Hospital Length of Stay
Time Frame: Third days or until hospital discharge, whichever occurs first
Duration of stay in the hospital
Third days or until hospital discharge, whichever occurs first
In-Hospital Mortality
Time Frame: Third days or until hospital discharge, whichever occurs first
Any death during hospitalization
Third days or until hospital discharge, whichever occurs first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Ary Serpa Neto, MD, MSc, PhD, Physician and Researcher
  • Study Director: Raffael PC Zamper, MD, Raffael

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

October 30, 2015

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VETLT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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