Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

NCT ID: NCT02037607

Last Updated: 2017-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Deep Vein Thrombosis

Keywords

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Deep vein thrombosis Children Pediatric Anti-coagulant Neurosurgical procedures Blood Clot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Daniel Fulkerson

Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel H Fulkerson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28474980 (View on PubMed)

Other Identifiers

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1208009386

Identifier Type: -

Identifier Source: org_study_id