Bleeding, Hemostatic Disorder, Liver Transplant; Complications
Conditions
Keywords
Liver Transplantation, Blood Coagulation Disorders, Blood Transfusion, Hemostasis, Thromboelastometry
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.
Interventions
OTHERUsual Care
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
OTHERThromboelastometry-Guided Therapy with Synthetic Factor Concentrates
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
Sponsors
Hospital Israelita Albert Einstein
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need of Any Blood Products Transfusion | 48 Hours | Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Complications Related to the Procedure | Third days or until hospital discharge, whichever occurs first | Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event |
| Duration of Mechanical Ventilation | Third days or until hospital discharge, whichever occurs first | Duration of mechanical ventilation in the post-operative period |
| Use of Synthetic Factor Concentrates or Antifibrinolytic | 48 Hours | Any use of synthetic factor concentrates or antifibrinolytic |
| Hospital Length of Stay | Third days or until hospital discharge, whichever occurs first | Duration of stay in the hospital |
| In-Hospital Mortality | Third days or until hospital discharge, whichever occurs first | Any death during hospitalization |
| ICU Length of Stay | Third days or until ICU discharge, whichever occurs first | Duration of stay in the intensive care unit |
Outcome results
None listed