Rotational Thromboelastometry (ROTEM) TRUE-NATEM Reference Value Validation in Liver Transplantation

Completed

Conditions studied: Coagulation in Liver Transplantation

In brief

Background: Rotational thromboelastometry (ROTEM) has been used widely in liver transplantation for coagulation management. However, a TRUE-NATEM (TRUE-Non-Activated Rotational Thromboelastometry) reference value has never been established. A TRUE-NATEM value is of clinical significance since no coagulation activators or reagents will be added to the blood sample for analysis. Therefore, the result will reflect the true coagulation profile of the patient. Methods: Non-citrated whole blood will be used for analysis. Blood will be drawn from the patient and transferred into a plastic reagent cup that has no reagent. Test will be performed within 4 minutes of blood draw to avoid activation of coagulation. Primary outcome measure will be clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF). The specific aims of the study are to establish a TRUE-NATEM reference value using Rotational Thromboelastometry (ROTEM®) in patients undergoing liver transplantation. Our hypothesis is that clotting time (CT), clot formation time (CFT) is prolonged and maximum clot firmness (MCF) decreased compared to healthy volunteers in patient undergoing liver transplantation due to synthetic coagulation factor deficiency.

Key facts

Study ID

NCT04282889

Run by

Thomas Jefferson University

People needed

40

Starts

2020-10-06

Expected to finish

2021-02-01

Last updated by the study team

2021-04-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion criteria are patients undergoing liver transplantation with English as their native language.

You may not qualify if…

• Exclusion criteria include patient's refusal, or on medical anticoagulation therapy. Informed consents will be obtained from the patients who agree to participate in this clinical study.

Where it is running

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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