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

NCT02239991 | Unknown

• 1 other identifier: 1986-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  intraoperative

Secondary Outcomes (5)

• mortality

  30 days

• Sepsis

  During intensive care unit

• Acute respiratory distress syndrome

  During intensive care unit

• Mechanical ventilation

  During intensive care unit

• Intensive care unit

  up to 30 days

Study Arms (2)

Historical control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Procedure: Thromboelastometry

Interventions

Thromboelastometry PROCEDURE

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

Also known as: point of care bleeding management, ROTEM, viscoelastic test

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• acute liver failure
• age under 18
• combined transplant
• re transplantation less than 30 days
• incomplete medical records, more than 20% of missing data.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (2)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-000, Brazil

ACTIVE NOT RECRUITING

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

RECRUITING

Related Publications (27)

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  PMID: 23478547 BACKGROUND

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• Liu LL, Niemann CU. Intraoperative management of liver transplant patients. Transplant Rev (Orlando). 2011 Jul;25(3):124-9. doi: 10.1016/j.trre.2010.10.006. Epub 2011 Apr 21.

  PMID: 21514137 BACKGROUND

• Ozier Y, Pessione F, Samain E, Courtois F; French Study Group on Blood Transfusion in Liver Transplantation. Institutional variability in transfusion practice for liver transplantation. Anesth Analg. 2003 Sep;97(3):671-679. doi: 10.1213/01.ANE.0000073354.38695.7C.

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  PMID: 10021474 BACKGROUND

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  PMID: 10861168 BACKGROUND

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• Trzebicki J, Flakiewicz E, Kosieradzki M, Blaszczyk B, Kolacz M, Jureczko L, Pacholczyk M, Chmura A, Lagiewska B, Lisik W, Wasiak D, Kosson D, Kwiatkowski A, Lazowski T. The use of thromboelastometry in the assessment of hemostasis during orthotopic liver transplantation reduces the demand for blood products. Ann Transplant. 2010 Jul-Sep;15(3):19-24.

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Blood Coagulation Disorders; Liver Cirrhosis; End Stage Liver Disease

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Luiz Henrique Ide Yamauchi, Physician

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz Henrique Ide Yamauchi, physician

CONTACT

+55112151-7806; luizyamauchi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

BR (2)