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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Utah
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00670735
First received: April 30, 2008
Last updated: February 8, 2013
Last verified: February 2013

April 30, 2008
February 8, 2013
April 2008
December 2020   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00670735 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Pediatric Hydrocephalus patients.

Pediatric Hydrocephalus
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
December 2020
December 2020   (final data collection date for primary outcome measure)

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 CSF diversion procedures will not be included in the Core Date Project:

• External ventricular drain(s)

Both
up to 18 Years
No
Contact: Marcie Langley 801-662-5364 marcie.langley@hsc.utah.edu
United States,   Canada
 
NCT00670735
27896, HCRN 001, 1RC1NS068943-01
No
University of Utah
University of Utah
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair: Jay Riva-Cambrin, MD Primary Children's Hospital
Principal Investigator: William Whitehead, MD Texas Children's Hospital
Principal Investigator: Jay Wellons, MD Children's Hospital of Alabama, University of Alabama
Principal Investigator: Abhaya Kulkarni, MD Sick Children's Hospital, Toronto, Ontario
Principal Investigator: Samuel R. Browd, M.D., Ph.D. Seattle Children's Hospital
Principal Investigator: Tamara D Simon, MD, MSPH University of Washington / Seattle Children's Hospital
Principal Investigator: David Limbrick, MD, PhD St. Louis Children's Hospital
Principal Investigator: Mandeep S Tamber, MD, PhD Children's Hospital of Pittsburgh of UPMC
University of Utah
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP