Trial Outcomes & Findings for Trauma Study: Early Warning of Progression Toward Hemodynamic Deterioration After Trauma (NCT NCT04912232)
NCT ID: NCT04912232
Last Updated: 2024-05-24
Results Overview
TERMINATED
NA
1 participants
patient data will be collected over 3-6 hours
2024-05-24
Participant Flow
Participant milestones
| Measure |
Trauma Patients
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS \>14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Detection of Occult Hemorrhage in Trauma Patients: Non-invasive monitoring of trauma patients
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trauma Study: Early Warning of Progression Toward Hemodynamic Deterioration After Trauma
Baseline characteristics by cohort
| Measure |
Trauma Patients
n=1 Participants
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS \>14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Detection of Occult Hemorrhage in Trauma Patients: Non-invasive monitoring of trauma patients
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: patient data will be collected over 3-6 hoursPopulation: Only 1 participant was enrolled was stable for 6 hours (no signs of hemodynamic deterioration). Therefore there was no data to analyze algorithm performance. Algorithm developed was to be trained to alarm under two circumstances indicating significant risk of ongoing hemorrhage progressing to shock: 1) a change from baseline, 2) development of prespecified patterns. This participant did not experience a triggering event, and therefore there was no data to be used to evaluate the algorithm.
Outcome measures
| Measure |
Trauma Patients
n=1 Participants
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS \>14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Detection of Occult Hemorrhage in Trauma Patients: Non-invasive monitoring of trauma patients
|
|---|---|
|
Algorithm Performance: Time of Alarm Before Onset of Deterioration
|
NA minutes
lack of events
|
PRIMARY outcome
Timeframe: patient data will be collected over 3-6 hoursPopulation: Only 1 participant was enrolled was stable for 6 hours (no signs of hemodynamic deterioration). Therefore there was no data to analyze algorithm performance. Algorithm developed was to be trained to alarm under two circumstances indicating significant risk of ongoing hemorrhage progressing to shock: 1) a change from baseline, 2) development of prespecified patterns. This participant did not experience a triggering event, and therefore there was no data to be used to evaluate the algorithm.
Outcome measures
| Measure |
Trauma Patients
n=1 Participants
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS \>14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Detection of Occult Hemorrhage in Trauma Patients: Non-invasive monitoring of trauma patients
|
|---|---|
|
Algorithm Performance: Sensitivity as Measured by for Alarm/no Alarm Outcome
|
NA percent
Lack of events
|
PRIMARY outcome
Timeframe: patient data will be collected over 3-6 hoursPopulation: Only 1 participant was enrolled was stable for 6 hours (no signs of hemodynamic deterioration). Therefore there was no data to analyze algorithm performance. Algorithm developed was to be trained to alarm under two circumstances indicating significant risk of ongoing hemorrhage progressing to shock: 1) a change from baseline, 2) development of prespecified patterns. This participant did not experience a triggering event, and therefore there was no data to be used to evaluate the algorithm.
Outcome measures
| Measure |
Trauma Patients
n=1 Participants
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS \>14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Detection of Occult Hemorrhage in Trauma Patients: Non-invasive monitoring of trauma patients
|
|---|---|
|
Algorithm Performance: Specificity as Measured by for Alarm/no Alarm Outcome
|
NA percent
lack of events
|
PRIMARY outcome
Timeframe: patient data will be collected over 3-6 hoursPopulation: Only 1 participant was enrolled was stable for 6 hours (no signs of hemodynamic deterioration). Therefore there was no data to analyze algorithm performance. Algorithm developed was to be trained to alarm under two circumstances indicating significant risk of ongoing hemorrhage progressing to shock: 1) a change from baseline, 2) development of prespecified patterns. This participant did not experience a triggering event, and therefore there was no data to be used to evaluate the algorithm.
Outcome measures
| Measure |
Trauma Patients
n=1 Participants
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS \>14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Detection of Occult Hemorrhage in Trauma Patients: Non-invasive monitoring of trauma patients
|
|---|---|
|
Algorithm Performance: Positive Predictive Value for Alarm/no Alarm Outcome
|
NA percent
lack of events
|
PRIMARY outcome
Timeframe: patient data will be collected over 3-6 hoursPopulation: Only 1 participant was enrolled was stable for 6 hours (no signs of hemodynamic deterioration). Therefore there was no data to analyze algorithm performance. Algorithm developed was to be trained to alarm under two circumstances indicating significant risk of ongoing hemorrhage progressing to shock: 1) a change from baseline, 2) development of prespecified patterns. This participant did not experience a triggering event, and therefore there was no data to be used to evaluate the algorithm.
Outcome measures
| Measure |
Trauma Patients
n=1 Participants
Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS \>14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Detection of Occult Hemorrhage in Trauma Patients: Non-invasive monitoring of trauma patients
|
|---|---|
|
Algorithm Performance: Negative Predictive Value for Alarm/no Alarm Outcome
|
NA percent
lack of events
|
Adverse Events
Trauma Patients
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