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NCT04282889 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Thomas Jefferson University.

Completed
Registry status
40
Enrollment target

NCT04282889 is a clinical trial that has completed, run by Thomas Jefferson University. The registered enrollment target is 40 participants.

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The verdict

NCT04282889 has completed, sponsored by Thomas Jefferson University.

COMPLETED
Registry status
40 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-10-06
Est. Completion 2021-02-01

Sponsor

Thomas Jefferson University

292 total trials

What the Registry Record Tells You About NCT04282889

The ClinicalTrials.gov registry entry for NCT04282889 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT04282889 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04282889 about?

NCT04282889 is a clinical study titled "Rotational Thromboelastometry (ROTEM) TRUE-NATEM Reference Value Validation in Liver Transplantation". 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 coa...

What is the current status of trial NCT04282889?

This trial is currently completed. The enrollment target is 40 participants. The study started on 2020-10-06. Estimated completion is 2021-02-01.

Who is sponsoring clinical trial NCT04282889?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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