Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant

September 15, 2014 updated by: Luiz Henrique Ide Yamauchi, Hospital Israelita Albert Einstein
A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease.

The fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis.

Routine tests of coagulation as prothrombin time (PT, INR) and activated partial thromboplastin time (APTT) although prolonged in cirrhotic patients cannot predict bleeding.

Global viscoelastic test of whole blood (TEG / ROTEM) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05652-900
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
        • Principal Investigator:
          • Luiz Henrique Ide Yamauchi, Physician
      • São Paulo, SP, Brazil, 05652-000
        • Active, not recruiting
        • Hospital Israelita Albert Einstein

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:

  • all patients from the national list of liver transplant assigned to have their transplant in Hospital Israelita Albert Einstein who gave free and clarified consent term.

Exclusion Criteria:

  • acute liver failure
  • age under 18
  • combined transplant
  • re transplantation less than 30 days
  • incomplete medical records, more than 20% of missing data.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Historical control
Group of patients that had their coagulopathy secondary to the liver transplant treated based on conventional laboratory tests. Before the implementation of thromboelastometry.
Experimental: Intervention
Group of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy
Procedure: Thromboelastometry
Group of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy
Other Names:
  • point of care bleeding management
  • ROTEM
  • viscoelastic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Units of packed red blood cells (PRBCs)
Time Frame: intraoperative
A prospective cohort study based on a point-of care protocol to monitor and manage the coagulopathy based on rotational thromboelastometry (ROTEM) in liver transplant with a historical control. Fifty patients will be managed by ROTEM protocol and will be compared with an equal number of historical controls treated according to the traditional protocol based on clinical and laboratory tests. The aim of this prospective study is to show a reduction in 20% of PRBCs transfusion during liver transplant.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days
All patients in interventional group will be followed for a period of 30 days.
30 days
Sepsis
Time Frame: During intensive care unit
Sepsis is defined as the presence (probable or documented) of infection together with systemic manifestations of infection. All patients in interventional group will be followed for a period of 30 days.
During intensive care unit
Acute respiratory distress syndrome
Time Frame: During intensive care unit
A chest X-ray will be done in all patients and will be followed for a period of 30 days. A chest X-ray can reveal which parts of your lungs have fluid in them
During intensive care unit
Mechanical ventilation
Time Frame: During intensive care unit
All patients in interventional group will be followed for a period of 30 days and will be noted the number of days under mechanical ventilation.
During intensive care unit
Intensive care unit
Time Frame: up to 30 days
Length of intensive care unit stay
up to 30 days

Collaborators and Investigators

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

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Luiz Henrique Ide Yamauchi, Physician, Hospital Israelita Albert Einstein

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

September 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1986-14

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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