Viscoelastic Tests-Guided Therapy In Liver Transplantation

Not Applicable

Completed

• Conditions: Bleeding; Hemostatic Disorder; Liver Transplant; Complications
• Interventions: Other: Usual Care; Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

• Registration Number: NCT03756948
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2015-10-30
• Study Completion: 2018-01-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-27
• Last Update Submitted: 2018-11-27
• Study First Posted: 2018-11-28
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Usual Care (Before)	Usual Care	No Thromboelastometry No Synthetic Factor Concentrates Usual Care
Thromboelastometry-Guided Therapy (After)	Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates	Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Primary Outcome Measures

Name	Time	Method
Need of Any Blood Products Transfusion	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.

Secondary Outcome Measures

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