Coagulation Disorder, BloodNCT05591014

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

A study testing Novel ROTEM interpretation software in people with Coagulation Disorder, Blood, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coagulation Disorder, Blood
What is being tested?: Novel ROTEM interpretation software
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 13 Apr 2023to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah
Salt Lake City, Utah, 84132

Other trials in United States

About this study

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
Being tested: Novel ROTEM interpretation software
Medical subject headings: Blood Coagulation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05591014
Study group	Role	What they receive
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. Receives: Device: Novel ROTEM interpretation software

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Proportion of Correct Clinician Responses Pre- and Post-application
Proportion of correct of clinician responses compared to a reference standard.
Measured: 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.
Measured: 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
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
Measured: At pre-application (baseline) and post-application (up to 15 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 202331 Dec 2024

First posted21 Oct 2022
Study start13 Apr 2023
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coagulation Disorder, BloodStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05591014
Sponsor's protocol ID: 00159279
Status last verified: Apr 2026
First submitted: 18 Oct 2022
Last updated: 27 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
ClinicalTrials.gov ID: NCT05591014
Acronym / sponsor ID: 00159279
Conditions: Coagulation Disorder, Blood
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Study start: 13 Apr 2023 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 21 Oct 2022 (actual)
Results: Posted 27 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Software Tutorial	Experimental	Device: Novel ROTEM interpretation softwareParticipants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Novel ROTEM interpretation softwareClinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software.	Device	Software Tutorial

Primary outcome

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.
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.

1 secondary outcome

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)

Results and safety

Results posted to the registry on 27 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Novel ROTEM Software Tutorial	26	26

Primary outcome: Overall Proportion of Correct Clinician Responses Pre- and Post-application

Time frame: At pre-application (baseline) and post-application (up to 15 minutes). Mean (95% Confidence Interval). Unit: Proportion of true positives

Measure	Software Tutorial n = 26
Pre-application	0.36 (0.27 to 0.46)
Post application	0.84 (0.79 to 0.89)

Software Tutorial: Risk Difference (RD): 0.48, p <0.001, Wilcoxon (Mann-Whitney)

Population analysed: 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM application.

Primary outcome: Overall Proportion of True Negative Clinician Responses Pre- and Post-application

Time frame: At pre-application (baseline) and post-application (up to 15 minutes). Mean (95% Confidence Interval). Unit: Proportion of true negatives

Measure	Software Tutorial n = 26
Pre-application	0.88 (0.764 to 0.997)
Post application	0.98 (0.956 to 1)

Population analysed: 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM application.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All-cause mortality, serious adverse events, and other adverse events were not systematically monitored or assessed as part of this study protocol. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Software Tutorial	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Novel ROTEM interpretation software in people with Coagulation Disorder, Blood, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Proportion of Correct Clinician Responses Pre- and Post-application (time frame: At pre-application (baseline) and post-application (up to 15 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05591014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.