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

Status: Recruiting
Location: See all (14) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Alabama
Children's Hospital of Alabama, University of Alabama
RECRUITING
Birmingham
California
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Maryland
Johns Hopkins Children's Center
NOT_YET_RECRUITING
Baltimore
Missouri
St. Louis Children's Hospital
RECRUITING
St Louis
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
RECRUITING
Nashville
Texas
Texas Children's Hospital
RECRUITING
Houston
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Canada
Alberta Children's Hospital
RECRUITING
Calgary
Sick Children's Hospital
RECRUITING
Toronto
British Columbia Children's Hospital
RECRUITING
Vancouver
Contact Information
Primary
Marcie Langley
marcie.langley@hsc.utah.edu
801-662-5364
Time Frame
Start Date: 2008-04
Estimated Completion Date: 2029-12
Participants
Target number of participants: 1400
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov