ROTEM Interpretation Software for Hemostatic Disorders

Overseen By Jacob Steenblik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Refusal to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if new software can help doctors better understand blood tests used to check for bleeding disorders. The focus is on improving doctors' ability to interpret these tests, known as ROTEM studies. The trial includes a tutorial where doctors read ROTEM results before and after using the novel ROTEM interpretation software. Suitable candidates for this trial are doctors in the University of Utah's Anesthesiology Department who have experience with these blood tests. As an unphased trial, this study offers doctors a unique opportunity to enhance their skills and contribute to advancing medical technology.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this software is safe for use in interpreting ROTEM studies?

Research has shown that rotational thromboelastometry (ROTEM) is safe for people. ROTEM provides real-time information about blood clotting, aiding doctors in decision-making during surgeries and other medical situations. It has been used safely in critical care settings, such as liver transplants and heart surgeries.

In this trial, the ROTEM interpretation software enhances doctors' understanding of ROTEM results without altering its function. Based on past use of ROTEM, no safety concerns have been identified with the software. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a novel ROTEM interpretation software designed to enhance the analysis of hemostatic disorders. Unlike traditional methods that rely heavily on manual interpretation of ROTEM studies, this software offers a more streamlined and potentially more accurate way to interpret results. By improving the precision and speed of diagnosis, this software could significantly improve patient outcomes and treatment planning in the future.

What evidence suggests that this ROTEM interpretation software is effective for hemostatic disorders?

Research has shown that new software for interpreting ROTEM tests may improve the accuracy of blood clotting assessments. ROTEM, or rotational thromboelastometry, evaluates blood clotting, which is crucial during surgeries and for individuals with bleeding disorders. Studies have found ROTEM useful in liver and heart surgeries, where quick clotting assessment is essential. In this trial, participants will use the novel ROTEM interpretation software to analyze a series of ROTEM studies before and after a tutorial. Although specific data on the software's effectiveness is limited, it aims to help doctors make better decisions by providing clearer information about blood clotting. This could lead to improved outcomes for patients requiring detailed clotting assessments. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for current residents and attending physicians in the University of Utah's Department of Anesthesiology, who have varying levels of experience with thromboelastography. Those not actively part of this department or unwilling to consent are excluded.

Inclusion Criteria

People who work at the University of Utah Department of Anesthesiology and have different levels of experience with a test called thromboelastography.

Exclusion Criteria

No longer an active member of the University of Utah Department of Anesthesiology

Refusal to consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Software Tutorial

Participants interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software

1-2 weeks

Follow-up

Participants are monitored for diagnostic accuracy over the course of the study

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Novel ROTEM interpretation software

Trial Overview The study is evaluating a new software designed to help doctors interpret ROTEM (rotational thromboelastometry) tests more accurately. These tests measure how well blood clots in patients with clotting disorders.

How Is the Trial Designed?

Group I: Software Tutorial Experimental Treatment 1 Intervention

Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. trial.medpath.com trial.medpath.com/clinical-trial/0a75ef1055d101f8/nct05591014-effectiveness-novel-software-rotem-interpretation

The Effectiveness of a Novel Software Program to ... - MedPath The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6714726/

The Double Hazard of Bleeding and Thrombosis in ... ROTEM analyses are useful for rapid assessment of global clotting function in various clinical situations including liver transplantation, cardiac surgery, ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05591014/the-effectiveness-of-a-novel-software-program-to-help-in-rotem-interpretation

The Effectiveness of a Novel Software Program to Help ... The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05591014?keyword=%22Coagulation%22

San Mateo Clinical Trial The Effectiveness of a Novel ... The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ajh.70074

TEG and ROTEM: Technology and Clinical Applications ... Recent advances have introduced automated, cartridge-based systems and novel detection methods—including resonance frequency and ultrasound- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11891846/

Role of rotational thromboelastometry in critical care settings ROTEM can provide real-time, dynamic information about clot formation and dissolution and prove to be a valuable tool for assessing coagulation in numerous ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622021535

Thromboelastometry assessment of hemostatic properties ... ROTEM is a reliable and sensitive assay for assessing therapeutics on hemostatic properties in mouse models with a bleeding or clotting disorder.

8. mdpi.com mdpi.com/2077-0383/12/12/3919

Rotational Thromboelastometry (ROTEM®) in Relation to ... This study aimed to assess the relationship between ROTEM parameters, the profile of inflammatory cytokines, and clinical outcomes in COVID-19 patients.