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

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

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 surgery

The number of participants with post-operative ultrasound without evidence of thromboembolism

Outcome measures

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place