Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study

Viscoelastic Tests-Guided Therapy In Liver Transplantation

Sponsors

Lead sponsor: Hospital Israelita Albert Einstein

Source Hospital Israelita Albert Einstein
Brief Summary

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.

Overall Status Completed
Start Date January 1, 2007
Completion Date January 1, 2018
Primary Completion Date October 30, 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Need of Any Blood Products Transfusion 48 Hours
Secondary Outcome
Measure Time Frame
Use of Synthetic Factor Concentrates or Antifibrinolytic 48 Hours
Clinical Complications Related to the Procedure Third days or until hospital discharge, whichever occurs first
Duration of Mechanical Ventilation Third days or until hospital discharge, whichever occurs first
ICU Length of Stay Third days or until ICU discharge, whichever occurs first
Hospital Length of Stay Third days or until hospital discharge, whichever occurs first
In-Hospital Mortality Third days or until hospital discharge, whichever occurs first
Enrollment 237
Condition
Intervention

Intervention type: Other

Intervention name: Usual Care

Description: Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components

Arm group label: Usual Care (Before)

Intervention type: Other

Intervention name: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Description: Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates

Arm group label: Thromboelastometry-Guided Therapy (After)

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Verification Date

November 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Usual Care (Before)

Arm group type: Active Comparator

Description: No Thromboelastometry No Synthetic Factor Concentrates Usual Care

Arm group label: Thromboelastometry-Guided Therapy (After)

Arm group type: Experimental

Description: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Acronym VETLT
Patient Data Undecided
Study Design Info

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov