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HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
This study is currently recruiting participants.
Verified by University of Utah, March 2009
First Received: April 30, 2008   Last Updated: March 10, 2009   History of Changes
Sponsored by: University of Utah
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00670735
  Purpose

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. The HCRN consists of four 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.


Condition
Pediatric Hydrocephalus

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 1400
Study Start Date: April 2008
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric Hydrocephalus patients.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670735

Contacts
Contact: Marcie Langley 801-662-5364 marcie.langley@hsc.utah.edu

Locations
United States, Alabama
Children's Hospital of Alabama, University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Chevis Shannon, MBA, MPH     205-939-5838     Chevis.Shannon@chsys.org    
Principal Investigator: Jay Wellons, MD            
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Sheila Nguyen, MPH, CCRP     832-822-4074     sxnguyen@texaschildrenshospital.org    
Principal Investigator: William Whitehead, MD            
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84118
Contact: Tracey Bach, BS     801-662-5344     tracey.bach@hsc.utah.edu    
Principal Investigator: Jay Riva-Cambrin, MD            
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Samuel R. Browd, M.D., Ph.D.     206-987-2544     samuel.browd@seattlechildrens.org    
Principal Investigator: Samuel R. Browd, M.D., Ph.D.            
Canada, Ontario
Sick Children's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Lindsay O'Connor, MSc     416-813-6456     lindsay.oconnor@sickkids.ca    
Principal Investigator: Abhaya Kulkarni, MD            
Sponsors and Collaborators
University of Utah
Investigators
Study Chair: Jay Riva-Cambrin, MD Primary Children's Medical Center
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
  More Information

Additional Information:
No publications provided

Responsible Party: Hydrocephalus Clinical Research Network ( John Kestle, MD )
Study ID Numbers: 27896, HCRN 001
Study First Received: April 30, 2008
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00670735     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Pediatric Hydrocephalus

Study placed in the following topic categories:
Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:
Nervous System Diseases
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus
Brain Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on July 02, 2009