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

November 2, 2022 updated by: richard holubkov, University of Utah
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1400

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • British Columbia Children's Hospital
        • Principal Investigator:
          • Mandeep S Tamber, MD, PhD
        • Principal Investigator:
          • Patrick McDonald, MD
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Sick Children's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's Hospital of Alabama, University of Alabama
        • Contact:
          • Anastasia Arynchyna, MPH
          • Phone Number: 205-638-5018
          • Email: arynch@uab.edu
        • Principal Investigator:
          • Curtis J Rozzelle, MD
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital of Los Angeles
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Johns Hopkins Children's Center
        • Contact:
        • Principal Investigator:
          • Edward Ahn, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's Hospital
        • Contact:
    • Ohio
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Principal Investigator:
          • Mandeep S Tamber, MD, PhD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
        • Contact:
        • Principal Investigator:
          • John C Wellons, III, MD, MSPH
        • Principal Investigator:
          • Chevis N Shannon, MBA, DrPH
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Principal Investigator:
          • William Whitehead, MD
    • Utah
      • Salt Lake City, Utah, United States, 84118
    • Washington
      • Seattle, Washington, United States, 98105

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

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric Hydrocephalus patients.

Description

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 Criteria:

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

• External ventricular drain(s)

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
Time Frame
To describe the number and characteristics of neurosurgical hydrocephalus patient events to HCRN Clinical Centers such as patient demographics, etiology of hydrocephalus, diagnostic information, as well as surgical and medical management decisions.
Time Frame: 5+ years
5+ years

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide this data to HCRN investigators to support hypothesis generation and study design development for clinical trials and observational studies to be carried out by the HCRN.
Time Frame: 5+ years
5+ years

Collaborators and Investigators

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

Sponsor

University of Utah

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Study Chair: Jay Riva-Cambrin, MD, Alberta Children's Hospital
  • Principal Investigator: Abhaya Kulkarni, MD, PhD, Sick Children's Hospital, Toronto, Ontario
  • Principal Investigator: Tamara D Simon, MD, MSPH, University of Washington / Seattle Children's Hospital

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.

Helpful Links

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

April 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (ESTIMATE)

May 2, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27896
  • 1RC1NS068943-01 (U.S. NIH Grant/Contract)
  • HCRN 001 (OTHER: HCRN Protocol Number)

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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