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.

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder, Blood
• Intervention / Treatment: Device: Novel ROTEM interpretation software

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Software Tutorial; Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software.	Device: Novel ROTEM interpretation software; Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Proportion of Correct Clinician Responses Pre- and Post-application	Proportion of correct of clinician responses compared to a reference standard.	At pre-application (baseline) and post-application (up to 15 minutes)
Overall Proportion of True Negative Clinician Responses Pre- and Post-application	Proportion of correct of clinician responses compared to a reference standard.	At pre-application (baseline) and post-application (up to 15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Correct Clinician Responses by Question Type Pre and Post Application	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	At pre-application (baseline) and post-application (up to 15 minutes)

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders
• Other Study ID Numbers: 00159279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes