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NCT02037607 Clinical Trial

Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

Deep Vein Thrombosis Clinical Trial

Official title:
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02037607
Other study ID # 1208009386
Secondary ID
Status Completed
Phase N/A
First received January 14, 2014
Last updated September 20, 2017
Start date September 2012
Est. completion date July 2015

Study information
Verified date September 2017
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 1 Month to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States James Whitcomb Riley Hospital for Children Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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