Trial Outcomes & Findings for Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures (NCT NCT02037607)
NCT ID: NCT02037607
Last Updated: 2017-10-20
Results Overview
The number of participants with post-operative ultrasound without evidence of thromboembolism
Recruitment status
COMPLETED
Target enrollment
100 participants
Primary outcome timeframe
within 72 hours after surgery
Results posted on
2017-10-20
Participant Flow
Participant milestones
| Measure |
Ultrasound Group (All)
All subjects in the study are in the same group. Study procedure is ultrasound
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
91
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ultrasound Group (All)
n=91 Participants
All subjects in the study are in the same group. Study procedure is ultrasound within 48 hours prior to surgery and a repeat within 72 hours after surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
91 Participants
n=91 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=91 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=91 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=91 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=91 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=91 Participants
|
|
Received baseline ultrasound
|
91 Participants
n=91 Participants
|
PRIMARY outcome
Timeframe: within 72 hours after surgeryThe number of participants with post-operative ultrasound without evidence of thromboembolism
Outcome measures
| Measure |
Ultrasound Group (All)
n=91 Participants
All subjects in the study are in the same group. Study procedure is ultrasound
|
|---|---|
|
Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism
|
91 Participants
|
Adverse Events
Ultrasound Group (All)
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
Heather Cero, Research Nurse Manager
Indiana University
Phone: 317-396-1298
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place