Thromboelastographic Guide for Blood Products in Cirrhotics

University of Modena and Reggio Emilia

Status and phase: Completed; Phase 2

Conditions: Coagulation Disorder; Liver Cirrhosis

Treatments: Procedure: Standard of care coagulation tests to guide blood products infusion; Procedure: Thromboelastography to guide blood products infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02362178

133/10

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Thromboelastography (TEG)

Experimental group

Description:

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.

Treatment:

Procedure: Thromboelastography to guide blood products infusion

Standard of Care (SOC)

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard of care coagulation tests to guide blood products infusion