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NCT05591014 Clinical Trial

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

Coagulation Disorder, Blood Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05591014
Other study ID # 00159279
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 13, 2023
Est. completion date December 31, 2024

Study information
Verified date January 2024
Source University of Utah
Contact Natalie Silverton, MD
Phone 8015816393
Email natalie.silverton@hsc.utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy sensitivity/specificity of clinician responses compared to a reference standard 1 year of data collection
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