Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant

Hospital Israelita Albert Einstein

Status: Unknown

Conditions: Evidence of Liver Transplantation; Liver Cirrhosis; Blood Coagulation Disorders

Treatments: Procedure: Thromboelastometry

Study type: Interventional

Funder types: Other

Identifiers

NCT02239991

1986-14

Details and patient eligibility

About

A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.

Full description

Patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease.

The fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis.

Routine tests of coagulation as prothrombin time (PT, INR) and activated partial thromboplastin time (APTT) although prolonged in cirrhotic patients cannot predict bleeding.

Global viscoelastic test of whole blood (TEG / ROTEM) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients from the national list of liver transplant assigned to have their transplant in Hospital Israelita Albert Einstein who gave free and clarified consent term.

Exclusion criteria

• acute liver failure
• age under 18
• combined transplant
• re transplantation less than 30 days
• incomplete medical records, more than 20% of missing data.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Historical control

No Intervention group

Description:

Group of patients that had their coagulopathy secondary to the liver transplant treated based on conventional laboratory tests. Before the implementation of thromboelastometry.

Intervention

Experimental group

Description:

Group of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy

Treatment:

Procedure: Thromboelastometry