N/A
N=100
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
Deep Vein Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT02037607 ↗Enrolled (actual)
100
Serious AEs
—
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism — 91 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism |
91 | — |
Summary
The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. The information gained from this study will help us determine when children children need to receive therapy to help prevent this type of blood clot from forming.
Eligibility Criteria
Inclusion Criteria
- Patients age 1 month-12 years undergoing elective neurosurgical procedures.
Exclusion Criteria
- Patients undergoing outpatient neurosurgical procedures
- Patients with known DVT
- Patients with known hypercoagulable state
- Patients at high risk for DVT (discretion of surgeon in consultation with the hematology service)
Data sourced from ClinicalTrials.gov (NCT02037607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.