Thromboelastographic Guide for Blood Products in Cirrhotics

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

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 Overview

• Status: Completed
• 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thromboelastography (TEG); 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; 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
Active Comparator: Standard of Care (SOC); 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; Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl

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

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Investigators: Principal Investigator: Lesley De pietri, MD, Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Liver Diseases; Hemorrhagic Disorders; Fibrosis; Hemostatic Disorders; Blood Coagulation Disorders; Liver Cirrhosis
• Other Study ID Numbers: 133/10