NCT02362178

Thromboelastographic Guide for Blood Products in Cirrhotics

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Modena and Reggio Emilia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis
• Coagulation Disorder

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2015-02-12
• Last updated: 2015-02-12