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

Pediatric Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00670735
• Other study ID #: 27896
• Secondary ID: HCRN 0011RC1NS06
• Status: Recruiting
• Start date: April 2008
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: University of Utah
• Contact: Marcie Langley
• Phone: 801-662-5364
• Email: marcie.langley[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hydrocephalus
• Pediatric Hydrocephalus

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Sick Children's Hospital	Toronto	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins Children's Center	Baltimore	Maryland
United States	Children's Hospital of Alabama, University of Alabama	Birmingham	Alabama
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Hydrocephalus Clinical Research Network