Trial Outcomes & Findings for Using Ultrasound Elastography to Predict Development of SOS (NCT NCT02483481)
NCT ID: NCT02483481
Last Updated: 2024-02-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
within 100 days of bone marrow transplant
Results posted on
2024-02-14
Participant Flow
Participant milestones
| Measure |
Shear Wave Ultrasound Elastography
shear wave ultrasound elastography: shear wave ultrasound elastography
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Ultrasound Elastography to Predict Development of SOS
Baseline characteristics by cohort
| Measure |
Shear Wave Ultrasound Elastography
n=45 Participants
shear wave ultrasound elastography: shear wave ultrasound elastography
|
|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 100 days of bone marrow transplantOutcome measures
| Measure |
Shear Wave Ultrasound Elastography
n=45 Participants
shear wave ultrasound elastography
|
|---|---|
|
Sensitivity and Specificity of US for VOD/SOS
Sensitivity
|
80 percentage of participants
|
|
Sensitivity and Specificity of US for VOD/SOS
Specificity
|
93 percentage of participants
|
SECONDARY outcome
Timeframe: within 100 days of bone marrow transplantdeath as noted in medical record
Outcome measures
| Measure |
Shear Wave Ultrasound Elastography
n=45 Participants
shear wave ultrasound elastography
|
|---|---|
|
Severity of SOS
|
2 Participants
|
Adverse Events
Shear Wave Ultrasound Elastography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 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