Thromboelastometry as a Tool to Predict Bleeding and Transfusion Requirement During Liver Transplantation

Predictions of Bleeding During Liver Transplantation With Thromboelastometry

Sponsors

Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Source Centre hospitalier de l'Université de Montréal (CHUM)
Brief Summary

Patients with cirrhosis present complex coagulation defects. Conventional coagulation tests (INR, platelets count) can not predict bleeding or blood product requirements during liver transplantation. Thromboelastometry (TEM)analyser measures the viscoelastic of the whole blood coagulation generation and lysis. TEM results are available more rapidly than conventional tests and give additional information regarding coagulation strengh, platelet function, and fibrinolysis.

Detailed Description

Historically, orthotopic liver transplantation (OLT) has been associated with major blood loss and the need for massive blood product transfusion . The cause of bleeding during OLT is multifactorial . The extensive surgical trauma plays a major role in the origin of bleeding. This bleeding can be accelerated by defects of the hemostatic system. Hemostatic defects can be divided into those present before the operation and those originating during the surgery. The latter can be classified according to the 3 main systems of hemostasis: coagulation, platelet function, and fibrinolysis. Hyperfibrinolysis is an important cause of non surgical bleeding during OLT .

A significant decrease in blood loss and blood product requirements has been observed during OLT over the past 10 years . This decrease can be explained by increase experience, improvements in surgical and anesthetic techniques, and a better understanding of the various hemostatic abnormalities encountered during OLT.

More than 10 years ago, Reyle-Hahn and Rossaint and Dupont et al stated that it is not necessary to correct coagulation defects before the anhepatic phase. More recently, some authors have a poor correlation between bleeding and the peripheral indices of coagulation in patients with chronic liver disease . These patients with cirrhosis are investigated by means of conventional tests for coagulation and primary hemostasis such as prothrombin time (INR), activated partial thromboplastin time (aPTT), platelet count, and skin bleeding time. Two important studies have raised serious questions about clinical use of INR in both measuring liver disease prognosis and in estimating bleeding risk thus calling into question many common and traditional clinical practices .

Now, it is cleat that conventional tests of coagulation (INR, platelet count, fibrinogen) are not able to predict blood product transfusion requirements and bleeding during liver transplantation.

A substantial body of evidence suggests that the use of blood products is associated with morbidity and mortality . Because 33% of liver recipients had acquired their liver disease through the transfusion of blood products , it is important to establish strategies aimed at decreasing blood losses and consequently the need for transfusion. The ability to predict intraoperative blood loss and transfusion requirements would be of great help to ensure adequate blood products and to enable appropriate therapy for patients at high risk of bleeding.

The ROTEM (TEM) thromboelastometry analyzer based on throboelastographic principles , measures the viscoelastic properties of whole blood coagulation generation and lysis. The instrument provides important global hemostatic information about the plasma-platelet-leucocyte interaction and clot tensile strength . TEM results are available more rapidly than those from laboratory-based conventional coagulation testing and also provide additional information regarding coagulation strength, platelet function, and fibrinolysis. Kang et al 39 using thromboelastogram (TEG) showed a decrease in red blood cells (RBC) use after the introduction of TEG monitoring.

ROTEM analysis includes plasmatic coagulation and fibrinolytic factors and inhibitors, as well as all circulating blood cells and provides clinically important information about quality of the final blood clot.

The aim of this observational study was to determine if ROTEM parameters were able to predict blood losses and transfusion of RBC during a liver transplantation.

Overall Status Unknown status
Start Date January 2015
Completion Date April 2016
Primary Completion Date April 2016
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
bleeding and transfusion 24 hours
Enrollment 70
Condition
Intervention

Intervention type: Other

Intervention name: ROTEM analysis

Description: 3 blood samples for ROTEM analysis

Arm group label: liver transplantation recepient

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- every patient who had a liver transplantation

Exclusion Criteria:

no

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Luc Massicotte, Doctor Principal Investigator CrCHUM
Overall Contact

Last name: luc Massicotte, Doctor

Phone: 5148908000

Phone ext: 36581

Email: [email protected]

Location
facility status contact contact_backup CHUM, Hôpital St-Luc Luc Massicotte, Doctor 514 890 8000 36581 [email protected]
Location Countries

Canada

Verification Date

January 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Centre hospitalier de l'Université de Montréal (CHUM)

Investigator full name: Luc Massicotte

Investigator title: Doctor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: liver transplantation recepient

Description: every patient who had a liver transplantation. 3 blood samples (2.7ml) for the ROTEM analysis

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov