Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

Completed

• Conditions: Deep Vein Thrombosis

• Registration Number: NCT02037607
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2017-03-14
• Results First Submitted QC: 2017-03-14
• Results First Posted: 2017-04-25
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism	within 72 hours after surgery	The number of participants with post-operative ultrasound without evidence of thromboembolism

Trial Locations

Locations (1)

James Whitcomb Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States