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

NCT05591014 | Completed Results FDA Device

• 1 other identifier: 00159279
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coagulation Disorder, Blood

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

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

Study Arms (1)

Software Tutorial

EXPERIMENTAL

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

Interventions

Novel ROTEM interpretation software DEVICE

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

Software Tutorial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Alastair Moody, MD
• Organization: University of Utah

alastair.moody@hsc.utah.edu

801-581-6393

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: The sensitivity/specificity and diagnostic accuracy of clinicians will be compared before and after the use of novel ROTEM app. The performance of more experienced clinicians will be compared to those with little to no experience in ROTEM. Analysis will be done using a mixed effects model to account for clustering of measurements within clinician groups. Inter-rater reliability analysis will be done to assess the similarity within clinician groups using the ICC.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: April 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)