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

Primary Purpose

Blood Coagulation Disorders, Evidence of Liver Transplantation, Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Thromboelastometry
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Coagulation Disorders focused on measuring Point of care, perioperative hemostasis, thromboelastometry, bleeding risk, end-stage liver disease, hepatic coagulopathy, whole blood coagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Israelita Albert EinsteinRecruiting
  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Historical control

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Units of packed red blood cells (PRBCs)
A prospective cohort study based on a point-of care protocol to monitor and manage the coagulopathy based on rotational thromboelastometry (ROTEM) in liver transplant with a historical control. Fifty patients will be managed by ROTEM protocol and will be compared with an equal number of historical controls treated according to the traditional protocol based on clinical and laboratory tests. The aim of this prospective study is to show a reduction in 20% of PRBCs transfusion during liver transplant.

Secondary Outcome Measures

mortality
All patients in interventional group will be followed for a period of 30 days.
Sepsis
Sepsis is defined as the presence (probable or documented) of infection together with systemic manifestations of infection. All patients in interventional group will be followed for a period of 30 days.
Acute respiratory distress syndrome
A chest X-ray will be done in all patients and will be followed for a period of 30 days. A chest X-ray can reveal which parts of your lungs have fluid in them
Mechanical ventilation
All patients in interventional group will be followed for a period of 30 days and will be noted the number of days under mechanical ventilation.
Intensive care unit
Length of intensive care unit stay

Full Information

First Posted
September 3, 2014
Last Updated
September 15, 2014
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT02239991
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Historical control
Arm Type
No Intervention
Arm Description
Group of patients that had their coagulopathy secondary to the liver transplant treated based on conventional laboratory tests. Before the implementation of thromboelastometry.
Arm Title
Intervention
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Thromboelastometry
Other Intervention Name(s)
point of care bleeding management, ROTEM, viscoelastic test
Intervention 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
Primary Outcome Measure Information:
Title
Units of packed red blood cells (PRBCs)
Description
A prospective cohort study based on a point-of care protocol to monitor and manage the coagulopathy based on rotational thromboelastometry (ROTEM) in liver transplant with a historical control. Fifty patients will be managed by ROTEM protocol and will be compared with an equal number of historical controls treated according to the traditional protocol based on clinical and laboratory tests. The aim of this prospective study is to show a reduction in 20% of PRBCs transfusion during liver transplant.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
mortality
Description
All patients in interventional group will be followed for a period of 30 days.
Time Frame
30 days
Title
Sepsis
Description
Sepsis is defined as the presence (probable or documented) of infection together with systemic manifestations of infection. All patients in interventional group will be followed for a period of 30 days.
Time Frame
During intensive care unit
Title
Acute respiratory distress syndrome
Description
A chest X-ray will be done in all patients and will be followed for a period of 30 days. A chest X-ray can reveal which parts of your lungs have fluid in them
Time Frame
During intensive care unit
Title
Mechanical ventilation
Description
All patients in interventional group will be followed for a period of 30 days and will be noted the number of days under mechanical ventilation.
Time Frame
During intensive care unit
Title
Intensive care unit
Description
Length of intensive care unit stay
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz Henrique Ide Yamauchi, physician
Phone
+55112151-7806
Email
luizyamauchi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Henrique Ide Yamauchi, Physician
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiz Henrique Ide Yamauchi, Physician
Phone
+551121513729
Email
luizyamauchi@gmail.com
First Name & Middle Initial & Last Name & Degree
Luiz Henrique Ide Yamauchi, Physician
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
SP
ZIP/Postal Code
05652-000
Country
Brazil
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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

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