RecruitingNCT00670735

HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)


Sponsor

University of Utah

Enrollment

1,400 participants

Start Date

Apr 1, 2008

Study Type

OBSERVATIONAL

Conditions

Summary

The Hydrocephalus Clinical Research Network (HCRN) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. In addition to philanthropic funding, the HCRN has also received an NIH NINDS Challenge Grant to support the network infrastructure which allows for the conduct of this and other network studies. The HCRN consists of multiple Clinical Centers and the Data Coordinating Center (DCC). The HCRN Core Data Project will obtain data about all neurosurgical hydrocephalus events from the network Clinical Centers, and create a database to be used by HCRN investigators. The ongoing maintenance of the Core Data Project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the HCRN. This multi-institutional database will be maintained throughout the lifetime of the HCRN, and may be useful for tracking trends in pediatric hydrocephalus over time. The Core Data Project will be an invaluable resource to the HCRN and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.


Eligibility

Max Age: 18 Years

Inclusion Criteria13

  • Information for all neurosurgical hydrocephalus patient events will be obtained from each HCRN Clinical Center and will be placed continuously into the Core Data Project. The first calendar year will be 2008, and data collection will continue for the duration of the existence of the HCRN. Neurosurgical hydrocephalus patient events include any operation for the treatment of documented hydrocephalus including the following:
  • Ventriculoperitoneal shunt
  • Ventriculoatrial shunt
  • Ventriculopleural shunt
  • Arachnoid cyst shunts
  • Subdural shunts
  • Lumboperitoneal shunts
  • Shunts replaced after treatment of infection
  • Shunts exposed during an operations but not revised
  • Endoscopic third ventriculostomies
  • Ommaya reservoir(s)
  • Ventricular access devices/reservoirs
  • Subgaleal shunts.

Exclusion Criteria2

  • The following temporary cerebrospinal fluid (CSF) diversion procedures will not be included in the Core Date Project:
  • External ventricular drain(s)

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Locations(14)

Children's Hospital of Alabama, University of Alabama

Birmingham, Alabama, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Johns Hopkins Children's Center

Baltimore, Maryland, United States

St. Louis Children's Hospital

St Louis, Missouri, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Sick Children's Hospital

Toronto, Ontario, Canada

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NCT00670735