Clinical trial NCT02239991: Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
Official title: Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Coagulation Disorders
Evidence of Liver Transplantation
Liver Cirrhosis
Keywords: Point of care
perioperative hemostasis
thromboelastometry
bleeding risk
end-stage liver disease
hepatic coagulopathy
whole blood coagulation
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Units of packed red blood cells (PRBCs)
timeFrame: intraoperative
Secondary outcomes:
measure: mortality
timeFrame: 30 days
measure: Sepsis
timeFrame: During intensive care unit
measure: Acute respiratory distress syndrome
timeFrame: During intensive care unit
measure: Mechanical ventilation
timeFrame: During intensive care unit
measure: Intensive care unit
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Luiz Henrique Ide Yamauchi, Physician
role: PRINCIPAL_INVESTIGATOR
References:
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