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

Not Applicable

• Conditions: Blood Coagulation Disorders; Liver Cirrhosis; Evidence of Liver Transplantation

• Registration Number: NCT02239991
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

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 Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-17
• Primary Completion: 2015-08
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Units of packed red blood cells (PRBCs)	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.

Secondary Outcome Measures

Name	Time	Method
mortality	30 days	All patients in interventional group will be followed for a period of 30 days.
Sepsis	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.
Intensive care unit	up to 30 days	Length of intensive care unit stay
Acute respiratory distress syndrome	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
Mechanical ventilation	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.

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, SP, Brazil