Thromboelastographic Guide for Blood Products in Cirrhotics

Phase 2

Completed

• Conditions: Liver Cirrhosis; Coagulation Disorder
• Interventions: Procedure: Thromboelastography to guide blood products infusion; Procedure: Standard of care coagulation tests to guide blood products infusion

• Registration Number: NCT02362178
• Lead Sponsor: University of Modena and Reggio Emilia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Study First Submitted: 2015-01-23
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-11
• Last Update Submitted: 2015-02-11
• Study First Posted: 2015-02-12
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thromboelastography (TEG)	Thromboelastography to guide blood products infusion	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.
Standard of Care (SOC)	Standard of care coagulation tests to guide blood products infusion	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.

Primary Outcome Measures

Name	Time	Method
Comparison in the amount of blood products transfused between the groups	48 hours from admission	Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups

Secondary Outcome Measures

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