NCT00670735 HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
| NCT ID | NCT00670735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Pediatric Hydrocephalus |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2008-04 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,400 participants in total. It began in 2008-04 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Jay Riva-Cambrin, MD
STUDY CHAIR
Alberta Children's Hospital
Frequently Asked Questions
Who can join the NCT00670735 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Pediatric Hydrocephalus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00670735 currently recruiting?
Yes, NCT00670735 is actively recruiting participants. Contact the research team at marcie.langley@hsc.utah.edu for enrollment information.
Where is the NCT00670735 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Aurora, United States, Baltimore, United States and 10 additional locations.
Who is sponsoring the NCT00670735 clinical trial?
NCT00670735 is sponsored by University of Utah. The principal investigator is Jay Riva-Cambrin, MD at Alberta Children's Hospital. The trial plans to enroll 1,400 participants.