Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

September 20, 2017 updated by: Daniel Fulkerson, Indiana University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • James Whitcomb Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 children between the ages of 1 month-12 years having an elective neurosurgical procedure at James Whitcomb Riley Hospital for Children.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism
Time Frame: within 72 hours after surgery
The number of participants with post-operative ultrasound without evidence of thromboembolism
within 72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Daniel H Fulkerson, M.D., Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208009386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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