Thromboelastographic Guide for Blood Products in Cirrhotics

NCT ID: NCT02362178

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-09-30

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.

Conditions

Liver Cirrhosis; Coagulation Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Thromboelastography to guide blood products infusion

Intervention Type: PROCEDURE

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 (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.

Group Type: ACTIVE_COMPARATOR

Standard of care coagulation tests to guide blood products infusion

Intervention Type: PROCEDURE

Patients received FFP (10 ml/kg) if INR\>1.8 and/or PLTS (10 units/Kg) If PLTs count \< 50000/μl

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Lesley De Pietri

Consultant Anaesthestetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lesley De pietri, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit

Other Identifiers

133/10

Identifier Type: -

Identifier Source: org_study_id