Thromboelastographic Guide for Blood Products in Cirrhotics

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
USE OF THROMBOELASTOGRAPHY TO GUIDE BLOOD PRODUCTS REPLACEMENT IN DECOMPENSATED CIRRHOTIC PATIENTS UNDERGOING INVASIVE PROCEDURES

Conditions
-----------------
Liver Cirrhosis, Coagulation Disorder

Intervention / Treatment
-----------------
* Procedure: Thromboelastography to guide blood products infusion
* Procedure: Standard of care coagulation tests to guide blood products infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thromboelastography (TEG)<br>Patients in the TEG group received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, only if INR was higher than 1.8 and r time longer than 40 minutes. They received platelets at the amount of 1 apheresis Unit, only if platelets count was lower than 50000/μl and MA was shorter than 30 millimeter. | Procedure: Thromboelastography to guide blood products infusion<br>* A TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time>40 mm and/or platelets (PLTs 10 units/Kg) for MA<30 mm<br>|
| Active Comparator: Standard of Care (SOC)<br>In the SOC group patients received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, when INR was higher than 1.8. They received platelets at the amount of 1 apheresis Unit, when platelets count was lower than 50000/μl. | Procedure: Standard of care coagulation tests to guide blood products infusion<br>* Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 48 hours from admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedure bleeding | Comparison of the number of patients having bleeding episodes after procedure between the study groups | 48 hours from admission | 
| Survival | Comparison of patients survival between the study groups | 90 days patient survival | 
| Transfusion related side effects | Comparison of the number of patients presenting transfusion side effects between the study groups | 48 hours from admission | 
| Procedure-related complications | Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups | during hospitalization (mean 4 weeks) | 
| Comparison between blood products costs between groups |  | 48 hours from admission |