Thromboelastographic Guide for Blood Products in Cirrhotics

University of Modena and Reggio Emilia60 enrolled

Overview

Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Liver Cirrhosis Coagulation Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic or imaging-proven liver cirrhosis of any etiology * INR\>1.8 and/or PLTs count \<50x103/μl Exclusion Criteria: * Ongoing bleeding * Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel * Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study * Presence of sepsis according to ACP-SCCP criteria * Hemodialysis performed within 7 days

Outcomes

Primary Outcomes

Comparison in the amount of blood products transfused between the groups

Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups

Time frame: 48 hours from admission

Secondary Outcomes

Post-procedure bleeding

Comparison of the number of patients having bleeding episodes after procedure between the study groups

Time frame: 48 hours from admission

Survival

Comparison of patients survival between the study groups

Time frame: 90 days patient survival

Transfusion related side effects

Comparison of the number of patients presenting transfusion side effects between the study groups

Time frame: 48 hours from admission

Procedure-related complications

Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups

Time frame: during hospitalization (mean 4 weeks)

Comparison between blood products costs between groups

Time frame: 48 hours from admission