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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Blood Coagulation Disorders, Evidence of Liver Transplantation, Liver Cirrhosis

Intervention / Treatment
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* Procedure: Thromboelastometry


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Historical control<br>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<br>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<br>* 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<br>* Other names: viscoelastic test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Units of packed red blood cells (PRBCs) | 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 | All patients in interventional group will be followed for a period of 30 days. | 30 days | 
| Sepsis | 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 | 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 | 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 | Length of intensive care unit stay | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point of care, perioperative hemostasis, thromboelastometry, bleeding risk, end-stage liver disease, hepatic coagulopathy, whole blood coagulation