Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 14, 2014
CompletedFirst Posted
Study publicly available on registry
January 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
April 25, 2017
CompletedOctober 20, 2017
September 1, 2017
2.8 years
January 14, 2014
March 14, 2017
September 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism
The number of participants with post-operative ultrasound without evidence of thromboembolism
within 72 hours after surgery
Eligibility Criteria
100 children between the ages of 1 month-12 years having an elective neurosurgical procedure at James Whitcomb Riley Hospital for Children.
You may qualify if:
- Patients age 1 month-12 years undergoing elective neurosurgical procedures.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Scherer AG, White IK, Shaikh KA, Smith JL, Ackerman LL, Fulkerson DH. Risk of deep venous thrombosis in elective neurosurgical procedures: a prospective, Doppler ultrasound-based study in children 12 years of age or younger. J Neurosurg Pediatr. 2017 Jul;20(1):71-76. doi: 10.3171/2017.3.PEDS16588. Epub 2017 May 5.
PMID: 28474980DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Heather Cero, Research Nurse Manager
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel H Fulkerson, M.D.
Indiana University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurosurgeon
Study Record Dates
First Submitted
January 14, 2014
First Posted
January 16, 2014
Study Start
September 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
October 20, 2017
Results First Posted
April 25, 2017
Record last verified: 2017-09