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

NCT00670735 | Recruiting

• 3 other identifiers: 27896HCRN 0011RC1NS068943-01
• Study Type: observational
• Target: 1,400
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Pediatric Hydrocephalus

Keywords

Pediatric Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• 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.

  5+ years

Secondary Outcomes (1)

• 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.

  5+ years

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Hydrocephalus patients.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (14)

Children's Hospital of Alabama, University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84118, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

Sick Children's Hospital

Toronto, Ontario, Canada

RECRUITING

Related Links

• Hydrocephalus Clinical Research Network

Study Officials

• Jay Riva-Cambrin, MD

  Alberta Children's Hospital

  STUDY CHAIR

• Abhaya Kulkarni, MD, PhD

  Sick Children's Hospital, Toronto, Ontario

  PRINCIPAL INVESTIGATOR

• Tamara D Simon, MD, MSPH

  University of Washington / Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Richard Holubkov, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcie Langley

CONTACT

801-662-5364; marcie.langley@hsc.utah.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 2, 2008
• Study Start: April 1, 2008
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

CA (3); US (11)