Viscoelastic Tests-Guided Therapy In Liver Transplantation (VETLT)

Hospital Israelita Albert Einstein

Status: Completed

Conditions: Liver Transplant; Complications; Hemostatic Disorder; Bleeding

Treatments: Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03756948

VETLT

Details and patient eligibility

About

BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation.

METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Deceased Donor Liver Transplantation
• Chronic Liver Disease

Exclusion criteria

• Acute Liver Failure
• Combined Transplantation
• Re-Transplantation is Less Than 30 Days After the First Transplant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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237 participants in 2 patient groups

Usual Care (Before)

Active Comparator group

Description:

No Thromboelastometry No Synthetic Factor Concentrates Usual Care

Treatment:

Other: Usual Care

Thromboelastometry-Guided Therapy (After)

Experimental group

Description:

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Treatment:

Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates