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

Last updated: December 13, 2024
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00670735
27896
HCRN 001
1RC1NS068943-01
  • Ages < 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion Criteria:

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

• External ventricular drain(s)

Study Design

Total Participants: 1400
Study Start date:
April 01, 2008
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Active - Recruiting

  • British Columbia Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Active - Recruiting

  • Sick Children's Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • Children's Hospital of Alabama, University of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Children's Hospital of Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Johns Hopkins Children's Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • St. Louis Children's Hospital

    St. Louis, Missouri 63110
    United States

    Active - Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Active - Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Primary Children's Hospital

    Salt Lake City, Utah 84118
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

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