Clinical trial NCT00670735: HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
Official title: HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Hydrocephalus
Keywords: Pediatric Hydrocephalus
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-05-02
Enrollment: 1400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Hydrocephalus patients.

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.


Eligibility 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 cerebrospinal fluid (CSF) diversion procedures will not be included in the Core Date Project:

• External ventricular drain(s)

Primary outcomes:
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.
timeFrame: 5+ years
Secondary outcomes:
measure: 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.
timeFrame: 5+ years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama, University of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Sick Children's Hospital
state: Ontario
Study officials:
affiliation: Alberta Children's Hospital
name: Jay Riva-Cambrin, MD
role: STUDY_CHAIR
affiliation: Sick Children's Hospital, Toronto, Ontario
name: Abhaya Kulkarni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington / Seattle Children's Hospital
name: Tamara D Simon, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Richard Holubkov, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: