Viscoelastic Tests-Guided Therapy In Liver Transplantation

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Transplant; Complications, Bleeding, Hemostatic Disorder

Intervention / Treatment
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* Other: Usual Care
* Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates


Participation Criteria
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Eligibility Criteria
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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

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of Any Blood Products Transfusion | 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 | Any use of synthetic factor concentrates or antifibrinolytic | 48 Hours | 
| Clinical Complications Related to the Procedure | 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 | Duration of mechanical ventilation in the post-operative period | Third days or until hospital discharge, whichever occurs first | 
| ICU Length of Stay | Duration of stay in the intensive care unit | Third days or until ICU discharge, whichever occurs first | 
| Hospital Length of Stay | Duration of stay in the hospital | Third days or until hospital discharge, whichever occurs first | 
| In-Hospital Mortality | Any death during hospitalization | Third days or until hospital discharge, whichever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Transplantation, Blood Coagulation Disorders, Blood Transfusion, Hemostasis, Thromboelastometry