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OpenTrials
Completed

NCT Number: NCT05591014

The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation

The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the accuracy of clinician interpretation.

Completed

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Key information

Conditions

Coagulation Disorder, Blood Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current residents and attending physicians in the University of Utah Department of Anesthesiology who have a range of experience and exposure to thromboelastography

Exclusion criteria

  • Refusal to consent or no longer an active member of the University of Utah Department of Anesthesiology

Treatment and study plan

Novel ROTEM interpretation software

Device

Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software.

Primary outcomes

  1. Overall Proportion of Correct Clinician Responses Pre- and Post-application

    Time frame: At pre-application (baseline) and post-application (up to 15 minutes)

    Proportion of correct of clinician responses compared to a reference standard.

  2. Overall Proportion of True Negative Clinician Responses Pre- and Post-application

    Time frame: At pre-application (baseline) and post-application (up to 15 minutes)

    Proportion of correct of clinician responses compared to a reference standard.

Secondary outcomes

  1. Proportion of Correct Clinician Responses by Question Type Pre and Post Application

    Time frame: At pre-application (baseline) and post-application (up to 15 minutes)

    Proportion of correct responses with 95% confidence intervals for cryoprecipitate, fresh frozen plasma, multiple-product scenarios, normal patterns, and platelets, shown separately for pre- and post-application

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2022
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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