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

Conditions:Women's Studies
Therapuetic Areas:Reproductive
Age Range:Any - 18
Start Date:April 2008
End Date:December 2020
Contact:Marcie Langley

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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.

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)
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