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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel ROTEM interpretation software | Device | Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel ROTEM Software Tutorial | Participants, 26 clinical anesthesiologists, will be asked to interpret a random series of 20 images of ROTEM studies before and a random series of 20 images of ROTEM studies after a tutorial on a novel ROTEM interpretation software. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
26 Anesthesiology residents at the University of Utah who completed both assessments pre- and post-ROTEM application.
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| ID | Title | Description |
|---|---|---|
| BG000 | Software Tutorial | Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software. Novel ROTEM interpretation software: Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data not collected. Participant demographics including age, race, and gender was not collected for this study as it was not pertinent to the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Proportion of Correct Clinician Responses Pre- and Post-application | Proportion of correct of clinician responses compared to a reference standard. | 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM application. | Posted | Mean | 95% Confidence Interval | Proportion of true positives | At pre-application (baseline) and post-application (up to 15 minutes) |
|
All-cause mortality, serious adverse events, and other adverse events were not systematically monitored or assessed as part of this study protocol
All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Software Tutorial | All-cause mortality, serious adverse events, and other adverse events were not systematically monitored or assessed as part of this study protocol. Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software. Novel ROTEM interpretation software: Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alastair Moody, MD | University of Utah | 801-581-6393 | alastair.moody@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2025 | Feb 12, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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.
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex data not collected. Participant demographics including age, race, and sex was not collected for this study as it was not pertinent to the study. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Overall mean of correct responses, pre-test | Clinicians (26) took a pre-test ROTEM assessment with 53 questions. | Mean | Inter-Quartile Range | proportion of correct responses |
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| Overall mean of true negatives, pre-test | Measure Description: Clinicians (26) took a pre-test ROTEM assessment with 53 questions. | Mean | Inter-Quartile Range | proportion of negative responses |
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| Mean proportion of correct responses by question type, pre-test | 26 clinicians completed a 53 question pre-test ROTEM assessment. Sensitivity were determined per question type. | Mean | Inter-Quartile Range | proportion of true positives |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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 | 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM application. | Posted | Mean | 95% Confidence Interval | Proportion of true positives | At pre-application (baseline) and post-application (up to 15 minutes) |
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| Primary | Overall Proportion of True Negative Clinician Responses Pre- and Post-application | Proportion of correct of clinician responses compared to a reference standard. | 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM application. | Posted | Mean | 95% Confidence Interval | Proportion of true negatives | At pre-application (baseline) and post-application (up to 15 minutes) |
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| Fresh Frozen Plasma, post-application |
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| Multiple-Product Scenarios, pre-application |
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| Multiple-Product Scenarios, post-application |
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| Normal Patterns, pre-application |
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| Normal Patterns, post-application |
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| Platelets, pre-application |
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| Platelets, post-application |
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| <0.001 |
| Risk Difference (RD) |
| 0.57 |
| 2-Sided |
| 95 |
Absolute difference for Fresh Frozen Plasma |
| Superiority |
| Wilcoxon (Mann-Whitney) | <0.001 | Risk Difference (RD) | 0.51 | 2-Sided | 95 | Absolute difference for Multiple-Product Scenarios | Superiority |
| Wilcoxon (Mann-Whitney) | <0.001 | Risk Difference (RD) | 0.42 | 2-Sided | 95 | Absolute difference for Normal Patterns | Superiority |
| Wilcoxon (Mann-Whitney) | <0.001 | Risk Difference (RD) | 0.38 | 2-Sided | 95 | Absolute difference for Platelets | Superiority |