Trial Outcomes & Findings for The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation (NCT NCT05591014)
NCT ID: NCT05591014
Last Updated: 2026-04-27
Results Overview
Proportion of correct of clinician responses compared to a reference standard.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
At pre-application (baseline) and post-application (up to 15 minutes)
Results posted on
2026-04-27
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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26
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Overall Study
COMPLETED
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26
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Software Tutorial
n=26 Participants
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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|---|---|
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Overall mean of correct responses, pre-test
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0.364549 proportion of correct responses
n=26 Participants
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Overall mean of true negatives, pre-test
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0.88 proportion of negative responses
n=26 Participants
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Mean proportion of correct responses by question type, pre-test
Cryoprecipitate
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0.11 proportion of true positives
n=26 Participants
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Mean proportion of correct responses by question type, pre-test
Fresh Frozen Plasma
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0.25 proportion of true positives
n=26 Participants
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Mean proportion of correct responses by question type, pre-test
Multiple-Product Scenarios
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0.18 proportion of true positives
n=26 Participants
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Mean proportion of correct responses by question type, pre-test
Normal Patterns
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0.49 proportion of true positives
n=26 Participants
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Mean proportion of correct responses by question type, pre-test
Platelet
|
0.56 proportion of true positives
n=26 Participants
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PRIMARY outcome
Timeframe: At pre-application (baseline) and post-application (up to 15 minutes)Population: 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM application.
Proportion of correct of clinician responses compared to a reference standard.
Outcome measures
| Measure |
Software Tutorial
n=26 Participants
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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|---|---|
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Overall Proportion of Correct Clinician Responses Pre- and Post-application
Pre-application
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0.36 Proportion of true positives
Interval 0.27 to 0.46
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Overall Proportion of Correct Clinician Responses Pre- and Post-application
Post application
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0.84 Proportion of true positives
Interval 0.79 to 0.89
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PRIMARY outcome
Timeframe: At pre-application (baseline) and post-application (up to 15 minutes)Population: 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM application.
Proportion of correct of clinician responses compared to a reference standard.
Outcome measures
| Measure |
Software Tutorial
n=26 Participants
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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|---|---|
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Overall Proportion of True Negative Clinician Responses Pre- and Post-application
Pre-application
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0.88 Proportion of true negatives
Interval 0.764 to 0.997
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Overall Proportion of True Negative Clinician Responses Pre- and Post-application
Post application
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0.98 Proportion of true negatives
Interval 0.956 to 1.0
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SECONDARY outcome
Timeframe: At pre-application (baseline) and post-application (up to 15 minutes)Population: 26 anesthesiology residents who completed both assessments (53 unique questions) pre- and post-ROTEM 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
Outcome measures
| Measure |
Software Tutorial
n=26 Participants
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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|---|---|
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Platelets, post-application
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0.94 Proportion of true positives
Interval 0.9 to 0.99
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Cryoprecipitate, pre-application
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0.11 Proportion of true positives
Interval 0.04 to 0.17
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Cryoprecipitate, post-application
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0.75 Proportion of true positives
Interval 0.65 to 0.86
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Fresh Frozen Plasma, pre-application
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0.25 Proportion of true positives
Interval 0.17 to 0.34
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Fresh Frozen Plasma, post-application
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0.82 Proportion of true positives
Interval 0.75 to 0.89
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Multiple-Product Scenarios, pre-application
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0.18 Proportion of true positives
Interval 0.09 to 0.27
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Multiple-Product Scenarios, post-application
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0.69 Proportion of true positives
Interval 0.59 to 0.79
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Normal Patterns, pre-application
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0.49 Proportion of true positives
Interval 0.42 to 0.56
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Normal Patterns, post-application
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0.91 Proportion of true positives
Interval 0.85 to 0.96
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Proportion of Correct Clinician Responses by Question Type Pre and Post Application
Platelets, pre-application
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0.56 Proportion of true positives
Interval 0.42 to 0.7
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Adverse Events
Software Tutorial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place