Thromboelastographic Guide for Blood Products in Cirrhotics

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02362178
• Other study ID #: 133/10
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2015
• Last updated: February 11, 2015
• Start date: February 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders
• Liver Cirrhosis

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Post-procedure bleeding	Comparison of the number of patients having bleeding episodes after procedure between the study groups	48 hours from admission	Yes
Secondary	Survival	Comparison of patients survival between the study groups	90 days patient survival	Yes
Secondary	Transfusion related side effects	Comparison of the number of patients presenting transfusion side effects between the study groups	48 hours from admission	Yes
Secondary	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)	Yes
Secondary	Comparison between blood products costs between groups		48 hours from admission	No